Understanding hysterectomy

Transcription

Understanding hysterectomy
Hormone Solutions
Contents
Introduction
4
What is hysterectomy?
4
Why is hysterectomy performed?
5
What are my surgical options?
6
Who requires hysterectomy?
7
How dangerous is hysterectomy?
8
Are there alternatives to hysterectomy?
9
Who is not a good candidate for hysterectomy?
12
Why do I need hormone supplements after surgery?
12
How do I prepare for hysterectomy?
14
What about aftercare?
19
When can I resume sexual relations?
21
What is the role of progesterone in humans?
22
What are the pros and cons of natural progesterone
treatment versus synthetic progestins?
24
Are there side-effects associated with using
natural progesterone?
26
What about homeopathic and herbal treatments?
27
How do I use PROFEME progesterone cream?
28
®
2
Why is PROFEME® progesterone cream the best?
32
About Lawley Pharmaceuticals
35
Our Mission Statement
36
Completed Clinical Studies
36
Internet Education Reference Sites
37
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Introduction
For many women the decision to undergo a hysterectomy is as
traumatic emotionally as well as it is physical. For conditions such
as uterine and ovarian cancer the decision is generally clear cut
and obvious, however for “lesser” conditions many women want
to leave no stone unturned in seeing a non-surgical resolution to
their problems. Hysterectomy is a serious and irreversible medical
procedure. There are numerous options with the type of surgery
involved in a hysterectomy and also the additional surgical “extras”
that may be performed as part of the procedure. In some situation
the ramification of these “extras” are not clearly identified to
patients prior to undergoing hysterectomy. This booklet explains
hysterectomy, the rationale behind hysterectomy, potential
after effects and complications of hysterectomy and importantly
alternatives to hysterectomy.
What is hysterectomy?
A subtotal or partial hysterectomy is surgical removal of the womb
(uterus) only. The cervix and ovaries are spared, so your menstrual
periods cease and you become infertile, but you do not experience
sudden menopause. Subtotal (partial) hysterectomies are performed
to control pelvic pain, abnormal bleeding or large fibroid tumors. It
is easier for the surgeon to perform than a total hysterectomy. The
woman who undergoes subtotal hysterectomy may develop cervical
cancer in later life, so she still needs to have an annual Pap smear.
A total or simple hysterectomy removes the uterus and cervix, so
sexual response to penetration may be limited in some women.
Total (simple) hysterectomy is the most common treatment for
cancer of the uterus or cervix. No annual Pap smear is required after
a total hysterectomy.
A radical hysterectomy involves removal of the uterus, ovaries,
fallopian tubes, cervix, lymph nodes, and sometimes the top
section of the vagina. The latter procedure, which removes all
4
internal reproductive organs, is called a TAHBSO (total abdominal
hysterectomy and bilateral salpingo-oophorectomy). TAHBSO
results in sudden menopause with uncomfortable hormonal
side-effects, such as hot flashes. One-third of all hysterectomies
are TAHBSO. Radical hysterectomy is performed for advanced
reproductive cancer, or if the woman is likely to develop ovarian
cancer later.
Why is hysterectomy performed?
Hysterectomy can be performed to treat:
• Large fibroid tumors (30% of all hysterectomies)
• Endometriosis (20% of all hysterectomies)
• Excessive menstrual bleeding (menorrhagia) with no definite
cause that does not respond to synthetic drug treatment (20%
of all hysterectomies)
• Prolapsed (fallen) uterus, endometrial hyperplasia, and pelvic
inflammatory disease (20% of all hysterectomies)
• Cancer of the uterus, cervix, or ovaries (10%)
Rarely, hysterectomy is performed when damage from childbirth or
catastrophic injury cannot be surgically repaired.
If a female’s karyotype contains a Y chromosome, then she is at high
risk for developing cancer, a medical specialist may recommend
removal of the ovaries (oophorectomy) as a preventive treatment.
FIBROID TUMORS www.uunderstandinguterinefibroids.com
ENDOMETRIOSIS www.understandingendometriosis.com
MENORRHAGIA www.understandingmenorrhagia.com
ENDOMETRIAL HYPERPLASIA
www.understandingendometrialhyperplasia.com
OOPHORECTOMY www.understandingoophorectomy.com
5
Hysterectomy is a serious and irreversible medical procedure.
There are both short and long-term ramifications that should be fully
considered before proceeding with a hysterectomy.
What are my surgical options?
To perform a hysterectomy, the surgeon reaches your internal
reproductive organs either through an incision in your lower abdomen,
through laparoscopic (keyhole) surgery via small abdominal incisions
or vaginally. Hysterectomy is performed under general anaesthetic.
The surgeon first cuts the ligaments that keep the uterus suspended
in your abdomen, then the supporting structures (pedicles) that
attach the uterus to neighboring internal organs, and finally ties off
the arteries that supply the uterus with blood.
Your surgical options depend on the amount of time and facilities
available, the extent of your disease, the size of your uterus, and the
skill of your surgeon.
If your uterus is enlarged it may require a large abdominal incision
for removal. Your incision will most likely extend vertically between
your pubic bone and your navel to enable the obstetrician to see the
internal organs well and to provide adequate room to manipulate
the instruments. The scar will be immediately visible because of the
size. Abdominal incisions are more painful than vaginal incisions, so
your hospital stay will be extended. Most hysterectomies (75%) are
performed abdominally.
If your hysterectomy is a planned (elective) operation, as most are,
then you have more choices. If your uterus is not greatly enlarged,
you may be a candidate for removal:
• Vaginally, through a small incision in the rear of the vagina,
which does not leave a visible scar and is suitable for prolapse
(where the uterus extends into the vaginal passage or beyond)
• Laparoscopically, with two or four tiny incisions in the abdomen through which a laparoscope camera and pen light are
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inserted, so the surgeon can see to disconnect the uterus from
its moorings and pull it out through the vagina, which leaves
only small scars and is suitable for a small uterus
• Abdominally through a ‘bikini cut’, a horizontal 10 centimeter
to 15 centimeter incision under your pubic hair line, where it is
not immediately visible
Your surgeon may remove:
• All of your reproductive organs entirely (radical), or
• Only the uterus above the cervix and retain the cervix for
sexual function (supracervically with worrelling), or
• Oophorectomy (ovaries only), or
• Salpingo-oophorectomy (fallopian tubes and ovaries)
Who requires hysterectomy?
The incidence of hysterectomy depends on where you live.
Hysterectomy is most prevalent in the U.S.A., especially in the
Midwest and South among African-American women. Every year,
over 550,000 American women have hysterectomies. It is the
second most prevalent form of female surgery. Fifty-five percent of
hysterectomies are performed on young women between the ages of
35 and 49. One-third of American women experience hysterectomy
by the age of 60. The high rate of American hysterectomy has been
questioned by foreign observers, who estimate 30% of American
hysterectomies are unnecessary. In recent years, the total number
of hysterectomies is decreasing, but more American women under
the age of 40 are hysterectomized. For some, it is for prevention of
ovarian and uterine cancer due to genetic predisposition. For most,
removal of the uterus is the recommended option by physicians
because conventional pharmaceutical drug treatments do not
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adequately treat uterine fibroids, heavy menstrual bleeding and/or
endometriosis.
The following table provides an estimate for the annual (2008)
incidence of hysterectomy in countries where the predominant
language is English:
COUNTRY
ESTIMATED
NUMBER OF
AFFECTED WOMEN
Australia
43,193
United Kingdom
130,734
United States
556,000
Canada
70,513
New Zealand
8,663
South Africa
96,413
How dangerous is hysterectomy?
All forms of surgery can have complications, and hysterectomy is no
exception. The danger of complications include:
• You may react badly to the anesthetic and require resuscitation.
• During the surgery, you may bleed excessively and require a
blood transfusion (up to 3.4% of patients).
• Your neighboring internal organs could be damaged if your
surgeon severs nerves near the pedicles (up to 1.8% of patients). Consequently, you may later experience involuntary
loss of urine from the bladder (incontinence). If the sides of the
bowel stick together because of adhesions, you may require
another surgery to free the blockage and allow the stool to
pass normally.
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• Blood clots (thrombi) can develop; if they travel to the lungs,
heart or brain (emboli) they can cause heart attack or stroke.
• If your incision becomes infected, you will require prescription
antibiotics and an extended hospital stay (up to 4% of patients).
An infection can cause sloughed skin or tissue death (necrosis).
• Fluid pocket formation and uneven pigmentation can result
from any surgery.
• The loss of any body part sets off a period of mourning and
adjustment, for which psychological counseling and antidepressants may be required. This is particularly true of hysterectomy because the sudden fluctuation of hormones induces
temporary mood swings, especially with the removal of the
ovaries.
• Over time, your remaining internal organs may fall downward
(prolapse) and you could have pain when eliminating waste, or
engaging in penetrative sex (dyspareunia), or during pelvic exams.
Your doctor should explain all of the possible complications to you
in detail and answer your questions as part of obtaining informed
consent prior to the operation. You will be required to sign a release
form acknowledging that these complications have been explained to
you and that you understand them and accept the possibility before
surgery can proceed. If you are unconscious at the time, due to injury
or complications, then your doctor explains the complications to your
next-of-kin or the person who holds your Power of Attorney, and
obtains a signed consent from him/her as your proxy.
Are there alternatives to hysterectomy?
Hysterectomy is a life-altering, permanent decision. It is female
castration and is irreversible. You have the legal right to obtain a
DYSPAREUNIA www.dyspareunia.com
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second, third and if necessary a fourth opinion. You have the ethical
right to discuss alternatives to hysterectomy with your doctor.
It is quite acceptable for you to ask your surgeon these questions
during the initial consultation:
1. How long have you been in practice?
2. How many hysterectomies have you performed?
3. How many of your patients have had complications?
4. What kind of complications did they have?
5. What other options can you offer me?
6. Why do you not favour these options?
Some of the surgical options you may want to discuss depending
upon why the hysterectomy is being recommended, include uterine
fibroid embolization (UFE), myomectomy (shelling out the fibroids
like pea pods), endometrial ablation (burning away the lining of the
uterus) and endometrial resection.
The majority of symptoms that lead to the recommendation for
hysterectomy are hormone-based. Synthetic pharmaceutical
hormones do not adequately treat most of the major symptoms that
lead to hysterectomy, especially uterine fibroids, endometriosis and
heavy menstrual bleeding. These conditions are the result of estrogen
dominance and are generally very responsive to the hormone
progesterone. Progesterone is the hormone that opposes the action
of estrogen and is vital for holding the uterine lining together during
the menstrual cycle. It is extremely important that patients who are
considering the hysterectomy option understand the principles of
estrogen dominance and know just why their body has changed so
radically. Estrogen dominance is reversible and if addressed early
enough, hysterectomy prevention through the use of progesterone
is a realistic option. For example, if hysterectomy is recommended
to treatment heavy periods it is usually the case that there is an
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overall progesterone deficiency and estrogen dominance which
leads to the heavy/uncontrolled bleeds. Synthetic progestagens
do not work in the same way as natural progesterone. Using a
pharmaceutical grade natural progesterone cream (PROFEME®,
Lawley Pharmaceuticals, Australia) generally results in control and
predictability of bleeding patterns, and achieves an improvement
in quality of life within three months.
This improvement usually continues
with extended use and can negate the
requirement for surgery. PROFEME will not
reverse continual “flooding”, an enlarged
or bulky uterus, prolapse or severe Stage
IV endometriosis.
To learn more about estrogen dominance
and progesterone deficiency download this
FREE estrogen dominance booklet from
www.understandingestrogendominance.
UTERINE FIBROIDS www.understandinguterinefibroids.com
HEAVY MENSTRUAL BLEEDING www.understandingheavyperiods.com
ESTROGEN DOMINANCE www.understandingestrogendominance.com
PROFEME® www.profeme.com
11
Who is not a good candidate for hysterectomy?
If you are very obese, or use alcohol, anabolic steroids, or marijuana,
then you are not a good candidate for any elective surgery. The
surgical team may decline to perform the hysterectomy until you
lose weight and stop taking drugs.
If you have a pre-existing medical condition that contributed to
the need for hysterectomy, like iron deficiency anemia, diabetes,
liver, heart, or lung disease, then you are not a good candidate for
surgery. Your doctor will likely recommend conservative medical
treatment because the benefits of surgery do not outweigh the risks.
Why do I need hormone supplements after surgery?
If your ovaries are removed (oophorectomy) during the surgery, then
you will experience immediate menopause because of the abrupt
drop in hormones circulating through your bloodstream. In young
women this early menopause has great significance and requires
comprehensive medical and psychological support both pre- and
post surgery. Even if you retain your ovaries after the hysterectomy,
chances are that you will experience menopause within the first five
years after surgery, although you still may be very young. Some of
the signs and symptoms of surgically-induced menopause are:
• Hot flashes
• Night sweats that disturb sleep (insomnia)
• Migraine headaches
• Lack of vaginal lubrication that makes intercourse painful
(dyspareunia)
• Fatigue
• Osteoporosis
• Heart palpitations
• Mood swings
• Weight gain
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• Shifting of fat from the buttocks and thighs to the abdomen
(apple shape)
• Diminished sex drive (lowered libido)
Menopause is normally a gradual, winding-down process, whereas
hysterectomy brings on a hormonal shock, especially when the
ovaries are removed. Your doctor may offer you estrogen replacement
after hysterectomy to prevent some of these unpleasant symptoms,
providing you do not have a hormone-dependent cancerous tumor.
If you have a form of cancer that is stimulated by hormones, then
you are not a candidate for hormone replacement therapy and your
recovery will likely be prolonged and intense.
When the ovaries are removed in a pre or perimenopausal women,
estrogen, progesterone and testosterone levels all dramatically
decline. Just replacing estrogen will address symptoms such as
hot flashes and night sweats; however, it will have minimal effect
on many other menopausal symptoms. Natural progesterone
(PROFEME®) and testosterone (ANDROFEME®) are essential to
maintain hormonal balance by assisting the nervous system and can
help you to deal with the emotional effects of instant menopause
induced by hysterectomy and ovarian removal, protection of bones
from thinning (osteoporosis), maintenance of sexual function, energy
EARLY MENOPAUSE www.understandingmenopause.biz
HOT FLASHES www.understandinghotflashes.com
NIGHT SWEATS www.understandingnightsweats.com
MIGRAINE HEADACHES www.understandingmhormonemigraine.com
DYSPAREUNIA www.dyspareunia.com
MOOD SWINGS www.understandingmoodchanges.com
LOWERED LIBIDO www.understandinglowlibido.com
ANDROFEME® www.androfeme.com
13
levels and blood sugar regulation. Natural estrogen (NATRAGEN®
or the adhesive estrogen skin patches) are better forms of estrogen
than synthetic tableted forms of estrogen.
How do I prepare for hysterectomy?
Consultations
Generally, a woman is referred to a qualified gynecologist or a
general surgeon by her family doctor because she has dysfunctional
uterine bleeding (DUB) or pre-cancer (endometrial hyperplasia).
Most often, the woman has experienced longstanding menstrual
problems that have not responded to birth control pills, synthetic
progestins (Provera® or Megace®), iron supplements, or tranexamic
acid (Cyklokapron®). Ultrasound may or may not reveal the cause
of the dysfunctional bleeding; 20% of cases have no known cause.
Hysterectomy is the last resort. (Not all family doctors are aware
of the benefits of PROFEME® progesterone cream for controlling
menstrual irregularities.) The gynecologist will investigate your
complaint with more detailed and possibly more invasive tests than
the family doctor did, then make a recommendation for treatment.
Hysterectomy is a permanent and irreversible treatment option.
Usually, a surgeon will not consider elective hysterectomy until a
woman has reached 30 years old and she is certain of not wanting more
children. This consideration is waived if cancer is diagnosed. You are
not obliged to accept the recommended hysterectomy. Remember
that you can always ask for time in which to get a second opinion.
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You can also ask the gynecologist to discuss alternative treatments
that spare the uterus, such as endometrial ablation, myomectomy or
uterine fibroid embolization and natural progesterone use.
If you decide to accept the hysterectomy, your gynecologist’s will
give you a ‘pre-op package’ up to three months before the surgery.
The package includes requisitions for bloodwork, urinalysis, a chest
x-ray, and pelvic ultrasound. It contains consent forms, directions
for aftercare and a schedule for follow-up. An appointment with the
anesthetist will be scheduled, so that you can be evaluated for any
problems that might arise with the anesthetic. If you smoke, take overthe-counter or prescription medication, herbs or vitamin supplements,
tell the anesthetist because these could affect your reaction to the
anesthetic. Bring the containers with you to your appointment.
You may also be booked in for a nursing consult. Your nurse will
teach you about aftercare and danger signs, and this teaching will
be repeated again after surgery to ensure you understand and
retain it. Nurses realize that you are under considerable stress and
your grasp of the material may not be as good as it might be under
ideal circumstances.
Choice of technique
Most women who decide to accept hysterectomy opt for general
anesthetic (complete unconsciousness), but sedation with a
local anesthetic can also be used. It takes about one to three
NATRAGEN® www.natragen.com
DYSFUNCTIONAL UTERINE BLEEDING (DUB)
www.understandingdysfunctionaluterinebleeding.com
15
hours for an abdominal hysterectomy. The complication rate for
abdominal hysterectomy is 9.3%. It takes about one or two hours
for a vaginal hysterectomy, but this technique requires more skill
than an abdominal approach. The complication rate for a vaginal
hysterectomy is 5.3%. Most general surgeons can easily perform an
abdominal hysterectomy with a vertical incision, but it requires an
experienced gynecologist to perform a vaginal hysterectomy. It is
more difficult for the surgeon to see the internal organs.
If your fibroid tumors are large or the uterus enlarged you may not be
given the option of a vaginal hysterectomy, because it is not physically
possible to remove the distended uterus through the vagina. (Some
fibroids reach the size of a large grapefruit.) It is very difficult to remove
the ovaries through the vagina. An expertly skilled gynecologist may
perform a laparoscopically-assisted vaginal hysterectomy (LAVH). The
gynecologist makes tiny holes in the abdomen for a small camera and
lights. The gynecologist removes the suspensory ligaments, pedicles,
and ties off the arteries feeding the uterus through the tiny holes,
and pulls the uterus out through a cut at the top of the vagina. The
complication rate for an LAVH is 3.6%. Hospital time is reduced to
one day and recovery time is only two weeks. However, LAVH is a
fairly new technique and not every hospital has the equipment, nor
every surgeon the skill to use it. LAVH takes about 120 minutes.
Remember that if your surgeon experiences problems during an
LAVH, he/she may abandon that approach and revert to a standard
abdominal incision (10 cm to 15 cm).
Cost
The price for a hysterectomy in Australia ranges from $2000 to $5,000
for a total abdominal hysterectomy, and from $1,700 to $5,100 for
an LAVH. The high cost of disposables used in LAVH is off-set by
the shorter hospital stay. You will require blood tests while in the
hospital to monitor you for blood loss leading to anemia, infection,
and hormonal fluctuations. Laboratory tests, pharmaceuticals and
medical imaging are separate costs.
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Costs are considerably higher in the United States and vary
depending upon medical insurance coverage. It is highly
recommended to find out the likely costs of the procedure prior to
making a final decision.
Preparing for your absence
Hysterectomy is always performed at a hospital on an in-patient
basis because it is major surgery; an out-patient procedure at a
clinic is not an option. You must make provisions for dependent
children for at least one week if you have an abdominal operation
and for at least three days if you have a vaginal operation. You
need to book a taxi or arrange for somebody to drive you home
from the hospital. You will convalesce at home for at least
four more weeks, and possibly eight weeks in the case of an
abdominal approach. During that time, you will not be able to
perform motions that pressurize the sutures and pull muscles,
such as vacuuming or lifting objects weighing more than five
pounds. Explain to your family or house-mates that they must
shoulder your household tasks while you recuperate to ensure a
good outcome.
Pre-op
Weaning
You must stop smoking two weeks before surgery. You cannot take
Vitamin E, herbs, aspirin, and anti-inflammatories for two weeks
before the surgery because these increase bleeding. Ask your doctor
if you must stop taking birth control pills, hormones, or Cyklokaperon®
before the surgery because they could cause clotting.
Packing
Bring one overnight bag. Pack a notebook and pen so you can jot
down any instructions. Take along a package of sanitary napkins,
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several pairs of cotton underwear, three nightshirts, a robe, and a
pair of slippers. Bring a toothbrush and toothpaste, shampoo and
conditioner, lip balm, deodorant, and moisturizer. You will need
a hairbrush and ponytail holder (if you have long hair). Keep a
phone- calling card and an emergency contact list. Remember that
cell phones can interfere with patients’ telemetry, so you may be
forbidden to use a cell within the hospital. You may want a long
pregnancy support pillow and a ‘swelly belly band’ for comfort
after your surgery. Bring your glasses, as you will not be allowed to
wear contact lenses for the surgery. Wear low-heeled, slip-on shoes
without laces so that your pelvis is stable and you do not have to
bend to put them on. You may want to bring an anti-nausea pill,
paper towels and a basin for the ride home.
Check-in
When you arrive at the hospital’s Admitting Department, the clerk
will register you, take your insurance information, give you an
identification bracelet, and give you directions to the gynecology
unit. The clerk will explain the hospital’s visiting and payment
policies. It is best not to bring large sums of cash or jewelry, but the
Admitting clerk can lock your valuables in a safe. Ask the clerk how
much it will cost to get a copy of your chart, and where and when
you can pick it up from Medical Records.
When you arrive on the in-patient floor, your nurse will record your
vital signs (temperature, pulse, respiration, and blood pressure),
height and weight. Your nurse will check your pre-op bloodwork,
urinalysis, and medical imaging results. If there are any abnormalities
or missing information, then the tests must be repeated. Your nurse
ensures that Blood Bank has at least two units of suitable blood
on hand for transfusion, in the event that you bleed excessively. If
you have a temperature, heart arrhythmia, breathing difficulties, or
high blood pressure, then your nurse notifies your surgeon and your
surgery may be cancelled or postponed while you get appropriate
treatment.
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Education
A physiotherapist or nurse-educator may teach you rehabilitative
exercises to restore the tone of your abdomen and bladder after
surgery. You can start isometric stomach muscle tightening about
four weeks post-op. You should start leg lifts and sit-ups with knees
bent about six weeks after your surgery, providing you will not have
had a bladder suspension with the hysterectomy. If the surgeon
works on your bladder or bowel during the hysterectomy, then you
must wait 12 weeks before exercising.
Prep
The night before surgery, your nurse places your belongings in a
bag labeled with your name. You must shower. A nursing assistant
will shave your abdomen and groin. You will get a light dinner and
then the nurse will place a sign over your bed reading ‘NPO’, which
means you are to have nothing to eat or drink — not even water
— after midnight. The nurse wants to ensure that your stomach
remains empty to minimize the chance that you will inhale (aspirate)
your own vomit during surgery. You may receive an enema and/
or stool softeners to clear out your bowel. If you wear dentures or
glasses, your nurse will keep them in a safe place.
Feel free to ask your nurse questions about the upcoming surgery
and aftercare, such as pain management and correct body mechanics
to reduce pressure on your incision. Your nurse can arrange for you
to see the hospital chaplain if you need spiritual reassurance.
What about aftercare?
Your nurse or physiotherapist will encourage you to get up and
walk soon after the surgery to prevent pooling of body fluids and
pneumonia. You can take a shower two days after your surgery.
Barring complications, you probably can return to work in one or two
months. You must return to have your surgeon remove your sutures in
one or two weeks. Most women can resume exercising in six weeks.
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Expect to have constipation for a week after the surgery. Keep
the following supplies available at home: A thermometer; loose
clothing; heating pads or hot water bottles; enough menstrual pads
for one month; several pillows; a basin for vomiting; prune juice;
Metamucil® or another fiber laxative; ice chips and a water jug; painkillers prescribed by your doctor; a multi-vitamin and mineral pill
recommended by your doctor or pharmacist.
You may benefit from the extra support of an elastic pressure
bandage or surgical garment for six weeks. You must wear it day
and night for two weeks to reduce swelling and help prevent skin
sagging. Then for the next four weeks, just wear it at night. Massage
the area daily to prevent contour irregularities from developing. The
final shape of your abdomen following the hysterectomy will not
appear for three months to one year. Expect some weight gain. You
will require a follow-up examination six weeks after surgery.
Surgery always produces bruising, swelling and scarring to some
degree. Hence, you may be disappointed if you expected an
immediate flattening of your abdomen. Your abdomen may be
numbed or you may have diminished sensation for up to a year
because nerves are severed. You must wear absorbent dressings for
the first 24 hours after surgery, because your wounds will drain a
combination of blood and injection fluid. Expect to bandage your
wounds for two weeks thereafter.
You may desire skin removal for cosmetic reasons, if your abdomen
was very enlarged, to prevent sagging after the hysterectomy. This
cosmetic procedure will present an additional cost and will likely
be done as a separate follow-up procedure, rather than at the time
of the hysterectomy. If you had a vertical incision, the red, raised
scar will gradually fade and flatten over the next six months. Wear
silicone sheet over the scar for two months and avoid sun exposure
for six months so the scar will not become darkly pigmented.
Avoid lifting more than five pounds during your recovery period. You
cannot perform duties like vacuuming that will strain your incision.
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Avoid stair-climbing, driving, and standing for prolonged periods.
Avoid taking aspirin and alcohol with your prescription pain-killers. If
you spike a temperature of 100.6°F or 38.1°C, or experience severe
pain, redness, drainage, swelling, or bleeding at the incision site,
then call your doctor.
When can I resume sexual relations?
Generally, you can resume penetrative sex after your six-week checkup. If you have stopped bleeding after four weeks, then you can have
non-penetrative sex. Do not be surprised if your desire (libido) is
low after major surgery with a rapid hormonal drop, especially if the
ovaries are removed. Your libido can be enhanced with testosterone
cream (ANDROFEME®), providing your doctor approves.
Seventy-one percent of women are greatly relieved after a
hysterectomy because their debilitating symptoms, such as heavy
menstrual bleeding and fatigue, disappear.
Some women develop sexual dysfunction after hysterectomy. If
the vagina is shortened to remove cancer, penetration by a penis
or even a finger can be uncomfortable or painful. If your cervix is
removed, you may find it difficult to reach orgasm because you miss
cervical tapping by a penis or finger. If your ovaries are removed,
you may find it impossible to produce enough estrogens for natural
lubrication, and may need to use a water-soluble lubricant for the
first time. Your sex partner needs to be educated about different
positions, angle of penetration, and alternative methods of
stimulation, in case you find penetration difficult. Also diminished
levels of the hormone testosterone can radically affect sexual desire
and lower libido.
LOWER LIBIDO www.understandinglowlibido.com
SEXUAL DYSFUNCTION
www.understandingfemalesexualdysfunction.com
21
Some women develop psychological issues surrounding
hysterectomy. They feel unfeminine and mourn their loss of
childbearing ability. Speaking to a licensed psychologist or
accredited sex therapist who is experienced with hysterectomy can
help. Most medical insurance plans do not provide reimbursement
for sex therapy, even though the sexual dysfunction resulted from
surgery. Sex therapy costs up to $300 per session, so ensure your
sex therapist has proper credentials:
• In Australia, sex therapists are certified by the Australian
Society of Sex Educators, Researchers and Therapists National
(ASSERT) www.assertnational.org.au
• In the U.K., sex therapists are accredited by the British Association for Sexual and Relationship Therapy (BASRT)
www.basrt.org.uk
• In the U.S.A. and Canada, sex therapists are certified by either
the American Association of Sex Educators, Counselors and
Therapists www.aasect.org or the American Board of Sexology
www.americanboardofsexology.com/certif.html
Verify with the appropriate governing body that your sex therapist is
a member in good standing before your treatment begins.
What is the role of progesterone in humans?
Progesterone is the hormone that regulates menstruation, supports
pregnancy, tempers the highly stimulatory effects of estrogen and
helps an embryo develop by providing a source of corticosteroids.
Natural progesterone is a steroid hormone derived from cholesterol
and is vital as a precursor hormone in the body’s production of
corticosteroids and glucocorticoids – steroids that help us deal with
stress and physical cellular/tissue repair. Progesterone is normally
produced by the corpus luteum in the ovaries and in the brains
of humans and animals. At about 8 to 10 weeks of pregnancy, the
placenta in pregnant females takes over progesterone production
from the ovaries. Progesterone is the pivotal hormone of pregnancy.
22
Women in their childbearing years experience cyclical progesterone
surges. In the beginning (follicular phase) of a menstrual cycle,
women have low progesterone levels equivalent to that in men,
children, and post menopausal women (less than 2 ng/ml of blood).
The small amount of progesterone present in males does not have a
feminizing effect on them. Progesterone calms mood in both sexes.
When a woman releases an egg for fertilization (ovulation), her
progesterone level spikes (greater than 5 ng/ml of blood). If the egg
(ovum) is fertilized, the corpus luteum (yellow body) in the ovary
secretes progesterone to maintain the pregnancy until the placenta
is large enough to take over production. Progesterone levels
increase to 400 ng/ml of blood, and taper off during the last month
of pregnancy to 200 ng/ml. After birth occurs and milk production
(lactation) begins, women experience “baby blues” because the
progesterone levels decrease abruptly.
Progesterone is a neurosteroid in the
brain that affects functioning of the
nerve synapses and the protective
myelin sheath of nerves. Researchers
are investigating the effects of
progesterone on memory, cognition,
and multiple sclerosis. Animal studies
suggest progesterone may protect
females from brain injury.
Progesterone molecule
Progesterone reduces spasms in smooth muscles. It is an antiinflammatory and decreases immune response. Progesterone
adjusts the body’s use of zinc, copper, fat, estrogen, collagen, and
blood clotting factors. It is a hormone that influences the function
SEXUAL DYSFUNCTION
PREGNANCY www.understandingpregnancy.biz
23
of the uterus, gall bladder, thyroid, bones, teeth, skin, ligaments,
tendons, and joints.
Progesterone reduces excessive menstrual bleeding by stabilizing
the endometrial uterine lining. A woman who is prone to miscarriage
(especially repeat first-term miscarriages) can use progesterone to
maintain the integrity of the placenta.
Mood changes, anxiety, depression, weight gain, irregular
periods, headache, migraine, infertility, miscarriage, uterine
fibroids, premenstrual syndrome (PMS) , post partum depression,
endometriosis, pregnancy problems, breast disorders and polycystic
ovarian syndrome (PCOS) are some of the medical conditions
associated with reduced progesterone production.
What are the pros and cons of natural progesterone treatment versus synthetic progestins?
Naturally occurring hormones (progesterone, testosterone and
estradiol) when incorporated into a cream are absorbed through
the skin (transdermally), so they avoid first-pass metabolism by the
liver. First-pass metabolism is a phenomenon where ingested drugs
are absorbed through the stomach and intestine, travel to the liver,
and are broken down to the extent that only a small fraction of the
active drug circulates to the rest of the body. This first-pass through
the liver greatly reduces the availability of the hormones to cells
by breaking them down into less active forms. Synthetic forms of
progesterone are called progestins or progestagens. Progestins
(such as medroxyprogesterone acetate (MPA), norethisterone,
levonorgestrel, drosperinone and desogestrel) are rapidly
metabolized by the liver due to the first-pass effect, so the amount
of hormone received is significantly reduced. All progestins have
side-effects not usually associated with natural progesterone. For
example medroxyprogesterone acetate has a very narrow spectrum
of action on the uterus and unlike progesterone has significant
side-effects. It is sold as Provera® as well as under many generic
24
brandnames and is commonly used to treat heavy menstrual bleeding
and in hormone replacement therapy. Medroxyprogesterone
acetate (MPA) may cause birth defects if taken during pregnancy.
Natural progesterone is the essential hormone of pregnancy. MPA
passes into breast milk and damages the infant, so it is not suitable
as a treatment for postnatal depression. MPA increases the risk of
blood clots, especially in smokers, can cause depression, suicidal
feelings, and dementia. It predisposes women to breast, ovarian,
EXCESSIVE MENSTRUAL BLEEDING
www.understandingheavyperiods.com
MISCARRIAGE www.understandingmiscarriage.com
MOOD CHANGES www.understandingmoodchanges.com
ANXIETY www.understandingestrogendominance.com
DEPRESSION www.understandingestrogendominance.com
WEIGHT GAIN www.understandingestrogendominance.com
IRREGULAR PERIODS www.understandingperimenopause.com
HEADACHE www.understandinghormonemigraine.com
MIGRAINE www.understandinghormonemigraine.com
INFERTILITY www.understandinginfertility.biz
PREMENSTRUAL SYNDROME (PMS)
www.understandingpremenstrualsyndrome.com
POST PARTUM DEPRESSION
www.understandingpostpartumdepression.com
PREGNANCY PROBLEMS www.understandingpregnancy.biz
BREAST DISORDERS www.understandingbreastdisorders.com
POLYCYSTIC OVARIAN SYNDROME (PCOS)
www.understandingpcos.com
25
and uterine cancer. If medroxyprogesterone acetate is used longterm, it increases the risk of stroke and heart attack. Published side
effects of synthetic medroxyprogesterone acetate include weight
gain, itchy skin rash, acne, hair loss, insomnia, bloating, menstrual
irregularities, vaginal discharge and tender breasts.
Progesterone receptors in the body are extremely fussy as to
what “key” switches them on. Progestins such as MPA do not
interact with the progesterone receptor in the same way as natural
progesterone. Because of this estrogen-dominant symptoms do
not respond to a progestin in the same way they do to natural
progesterone. Progestins and natural progesterone are worlds
apart in their effect and can never be compared for overall effect
in treating many of the symptoms such as heavy bleeding, uterine
fibroids and endometriosis that so often results in the hysterectomy
option.
Are there side-effects associated with using natural
progesterone?
PROFEME® natural progesterone cream has very low toxicity. The
most common problems associated with progesterone treatments
are that they can cause symptoms similar to the feeling of
pregnancy:
• Tender breasts
• Fatigue
• Mood swings
• Constipation or diarrhoea
• Headache
• Muscle or joint pain
• Occasionally breakthrough bleeding (spotting)
• Fluid retention
• Dizziness
26
If these occur, a simple adjustment of dose
usually resolves the problem. Side-effects,
if they occur, are usually experienced at the
onset of treatment and are considered a
positive sign. Side-effects usually resolve
themselves fully within 10 days of a dose
reduction and often sooner.
For comprehensive information on the safe and
effective use of progesterone in women view
www.profeme.com or download the booklet
above.
What about homeopathic and herbal treatments?
Homeopathy is a complementary therapy. Homeopaths claim that
like cures like. Essentially, homeopaths believe that if a substance
causes a disease, then you can cure it by taking a very minute,
diluted amount of the same substance.
Homeopathic treatments contain NO progesterone or testosterone,
nor have they been demonstrated to cause any change in
testosterone or progesterone levels.
The herb Chaste berry (Vitex agnus castus) does not contain
progesterone, but it may indirectly help you produce progesterone
over the course of several months by stimulating your pituitary
gland to produce luteinizing hormone. Chaste berry has unpleasant
side effects, such as an itchy skin rash, nausea, dry mouth, digestive
upset, hair loss, headaches, rapid heartbeat, and bleeding between
periods. Vitex is called chaste berry and monk’s pepper because it
was used for centuries to reduce libido. Do not use chaste berry if
you are pregnant, breastfeeding, or have endometriosis, fibroids,
cancer of the ovaries or breast, schizophrenia, or Parkinson’s
disease. It is highly unlikely that chaste berry is sufficiently potent to
stimulate progesterone production that will address symptoms that
may require hysterectomy.
27
Wild yam treatments sold in health food stores contain a steroid
substrate called diosgenin, which is chemically similar to
progesterone, but does not act like progesterone within the body.
Humans cannot convert diosgenin into progesterone – a point
often misrepresented by marketers of wild yam products. Wild yam
treatments are totally ineffective as a progesterone supplement or
for treating heavy bleeding, uterine fibroids or endometriosis that
may lead to hysterectomy.
How do I use PROFEME® progesterone cream?
The aim of treatment with PROFEME® progesterone cream is to mimic
the body’s normal natural hormone production as much as possible.
PROFEME® dose applicators are marked in 0.5ml doses. You must tailor
the strength, amount and the number of days you apply the cream to
your individual requirements. Your doctor or health care professional
may alter the dose recommended in this booklet. Women’s hormonal
cycles are more complex than the hormone profile of men.
PROFEME® 3.2% and 10% progesterone cream is used to control the
symptoms of benign breast disorders during premenstrual syndrome
(PMS), menopause, and perimenopausal symptoms. PROFEME®
treats other progesterone-deficiency conditions, such as surgical
menopause from hysterectomy, ovarian cysts, uterine fibroids and
fibrocystic breasts. If you have had a hysterectomy, the doctor may
prescribe estrogen-only for menopausal symptoms to manage
hot flashes and night sweats.
In hysterectomized women it is
very important that unopposed
estrogen must be supported with
natural progesterone to prevent
symptoms of estrogen dominance.
Perimenopausal and menopausal
women can evaluate improvement
in their symptoms when using
PROFEME® progesterone cream
28
using the online Progesterone Deficiency Symptoms Assessment
questionnaire at http://www.hormonesolutions.com.au/PDA . Ideally
the questionnaire should be taken before starting PROFEME® and
again after 3 months of treatment.
PROFEME® progesterone cream is supplied in two strengths – 3.2%
and 10% w/v containing 32mg progesterone per ml and 100mg
progesterone per ml. Each tube is supplied with a graduated dose
- measuring applicator.
BENIGN BREAST DISORDERS
www.understandingbreastdisorders.com
PREMENSTRUAL SYNDROME (PMS)
MENOPAUSE www.understandingmenopause.biz
PERIMENOPAUSAL SYMPTOMS www.understandingperimenopause.com
HYSTERECTOMY www.understandinghysterectomy.com
OVARIAN CYSTS www.understandingovariancysts.com
FIBROCYSTIC BREASTS
www.understandingfibrocysticbreastdisease.com
ESTROGEN DOMINANCE
www.understandingestrogendominance.com
29
Recommended starting doses for using PROFEME® natural
progesterone cream are as follows:
• Peri-menopausal women (including moderate severity
heavy bleeding, uterine fibroids and endometriosis). Apply
1ml of PROFEME® 3.2% cream via measured applicator (32mg
progesterone) daily or in divided doses from day 12-26 of each
menstrual cycle. If a menstrual period starts prior to day 26
cease using PROFEME® and consider the first day of bleeding
as Day 1 of the new cycle. This is a common occurrence when
initiating treatment in peri-menopausal women and should be
considered a sign that the treatment is having a positive effect.
Symptoms abate in 2nd or 3rd month of use. Where symptoms
are more severe or unresponsive to PROFEME® 3.2% use
PROFEME® 10% cream 100- 200mg (1-2mL daily).
• Pre-menstrual syndrome (PMS). Apply 1ml of PROFEME®
3.2% cream via measured applicator (32mg progesterone) daily
or in divided doses from day 12-26 of each menstrual cycle.
Significant alterations to this dosage may be made to achieve a
crescendo effect 4-5 days prior to menses. Symptoms abate in
2nd or 3rd month of use.
• Pre-menstrual dysphoric disorder (PMDD). Apply 0.5 - 1ml
of PROFEME® 10% cream via measured applicator (50-100mg
progesterone) daily or in divided doses from day 12-26 of each
menstrual cycle. Significant alterations to this dosage may be
made to achieve a crescendo effect 4-5 days prior to menses.
Symptoms abate in 2nd or 3rd month of use.
• Endometriosis, Severe menstrual bleeding/flooding and
Postpartum depression. Apply 1.0 - 2.0ml of PROFEME® 10%
cream via measured applicator (100-200mg progesterone) daily
or in divided doses depending upon the severity of the condition. In reproductive cyclical women initiate treatment on a day
12-26 basis, but this may need to be increased to three weeks
use in every four if symptoms/pain emerge upon withdrawl.
• Infertility/Repeated First-term Miscarriage. Luteal phase
and first trimester corpus luteal support. Apply 1ml of
PROFEME® 10% cream (100mg progesterone) daily or in
30
divided doses via measured applicator from day 12-26 of each
cycle until pregnancy is confirmed and then 1-2ml daily on a
continuous basis until at least week 13 or until full term.
Before conceiving, a woman prone to miscarriage should use
PROFEME® 3.2% cream from days 12 to 26 of the cycle until
the pregnancy is confirmed. If spotting occurs at week 6 or 7 of
pregnancy, a high dose of 100 to 200 mg progesterone cream
(PROFEME® 10%) twice or three times daily. Often, women use
PROFEME® natural progesterone cream until the baby is full term
(40 weeks of gestation).
Note: Amount and duration of application for all conditions must be
tailored to individual requirements
PROFEME® Prescribing Information and Consumer Medicine Information
can be downloaded from http://www.profeme.com.
ProFeme®
ProFeme® 3.2
3.2
Cream containing 3.2% w/v (32mg/mL) Progesterone B.P (Prog -4 -ene - 3.20 dione)
1
Where to apply PROFEME® cream?
Always apply PROFEME® cream
to clean dry areas of skin. The
best area to use PROFEME® is
the inner forearms or the upper
thighs. Never apply the cream to
broken or damaged skin. Do not
use PROFEME® on the genital
area. PROFEME® cream should
be applied at approximately the
same time each day.
The Inner Arms
The Upper Thighs
How often to apply PROFEME® cream
Because each woman has a different progesterone requirement there is
not a single "correct" dose of PROFEME®.
PROFEME® is available in two different strengths (3.2% and 10%) and
your doctor will have prescribed the strength and dose suitable for your
individual condition.
Should you be unsure of the exact dose and frequency of dose contact
your doctor. A dosage guide follows.
How to use PROFEME®
Your doctor or pharmacist will explain how to apply PROFEME®.
Follow all directions exactly as they are explained. If you are unclear
clarify with your doctor or pharmacist prior to use.
The dose of PROFEME® will be determined for you by your doctor. This
dose will be specific to your condition and should not be varied unless
directed to do so by your doctor.
If you do not understand the instructions on the label, ask your doctor
or pharmacist for help.
Opening the tube
To open the tube remove the cap and peel off the foil seal. Dispose of
the foil seal and replace the cap firmly after using the cream.
www.hormonesolutions.com
2
0.5
Prior to using PROFEME®
PROFEME® cream should not be used if you are allergic to
progesterone, or any of the ingredients contained within PROFEME®.
These are listed at the end of this leaflet. This product contains almond
oil and macadamia nut oil.
Do not use PROFEME® if you have kidney disease, liver disease,
unexplained abnormal vaginal bleeding or herpes during pregnancy
(herpes gestationis).
Check with your doctor or pharmacist if you are unsure about whether
you have any of these conditions before using PROFEME®.
If you are taking other medications check with your doctor or
pharmacist before using PROFEME®.
PROFEME® is best applied to the inner forearm or upper thigh. The
area should be clean and dry.
No perfume, deodorant or moisturising creams or gels should be used
on the area because this may interfere with PROFEME® from being
absorbed.
Do not use PROFEME® after the expiry date which is printed on the
base (crimp) of the tube.
Do not use PROFEME® if the foil seal at the top of the tube is
damaged or broken.
PROFEME® is not indicated for use in children.
1.5
What PROFEME® is used for?
PROFEME® contains the active ingredient progesterone.
This form of progesterone is identical to the progesterone produced
by the ovaries of women. Progesterone plays an important role in
the menstrual cycle, reproduction, hormone production, mood, fluid
balance, metabolism, energy levels and well-being in women. Where
women suffer from a deficiency of progesterone one or more of
these areas may be affected and PROFEME® provides progesterone
to address this deficiency. The skin readily absorbs progesterone
and PROFEME® is a clean, simple and effective means of getting
progesterone into the body.
Usual dose of PROFEME®
Menopausal Women
Apply 1ml of PROFEME® 3.2% cream (32mg progesterone) via
measuring applicator daily or in divided doses for 25 days per calendar
month or for 3 weeks in every four. Symptoms abate in 2nd or 3rd month
of use.
Perimenopausal Women
measuring applicator daily or in divided doses from day 12-26 of
menstrual cycle. Symptoms abate in 2nd or 3rd month of use.
Premenstrual Syndrome (PMS)
measuring applicator daily or in divided doses from day 12-26 of cycle.
Significant alterations to this dose may be made to achieve a crescendo
effect 4-5 days prior to menses. Symptoms abate in 2nd or 3rd month of
use.
PROFEME® 3.2% CMI
ProFeme®
ProFeme® 10
10
Cream containing 10% w/v (100mg/mL) Progesterone B.P (Prog -4 -ene - 3.20 dione)
CONSUMER MEDICINE INFORMATION
Do not use PROFEME® after the expiry date which is printed on the
base (crimp) of the tube.
Do not use PROFEME® if the foil seal at the top of the tube is
damaged or broken.
PROFEME® is not indicated for use in children.
1
2
1.5
Always apply PROFEME® cream to clean dry areas of skin. The best
area to use PROFEME® is the inner forearms or the upper thighs. Never
apply the cream to broken or damaged skin. Do not use PROFEME® on
the genital area. PROFEME® cream should be applied at approximately
the same time each day.
How often to apply
PROFEME® cream
Because each woman has
a different progesterone
requirement there is not
The Inner Arms
a single “correct” dose of
PROFEME®. PROFEME® is
available in two different
The Upper Thighs
strengths (3.2% and 10%)
and your doctor will have
prescribed the strength
and dose suitable for your
individual condition. Should
you be unsure of the exact dose and frequency of dose contact your
doctor. A dosage guide follows.
Usual dose of PROFEME®
How to use PROFEME®
Your doctor or pharmacist will explain how to apply PROFEME®.
Follow all directions exactly as they are explained. If you are unclear
clarify with your doctor or pharmacist prior to use.
The dose of PROFEME® will be determined for you by your doctor.
This dose will be specific to your condition and should not be varied
unless directed to do so by your doctor. If you do not understand the
instructions on the label, ask your doctor or pharmacist for help.
Opening the tube
To open the tube remove the cap and peel off the foil seal. Dispose of
the foil seal and replace the cap firmly after using the cream.
Measuring the correct dose of PROFEME® Cream
A measuring applicator (syringe style) in a sealed sleeve is enclosed
in the PROFEME® box. The dose of PROFEME® is measured in
millilitres. The applicator is marked with 0.5ml graduations for dosing
accuracy. Your doctor will have determined which dose is appropriate
for you. To measure the correct dose of cream insert the tip of the
Progesterone should not be used by women with any of the following
conditions:
•
CH3
•
•
•
•
C=O
Severe liver disease ie. cholestatic jaundice, Rotor syndrome or
Dubin-Johnson syndrome
Any unexplained abnormal vaginal bleeding
History of herpes gestationis
Jaundice of pregnancy
Known sensitivity to PROFEME® cream or any of its individual
components
Adverse Reactions
Because PROFEME® contains the hormone identical to that produced
by the human ovary side effects are usually minimal. If experienced
these may include breast tenderness and swelling, fluid retention or
slight vaginal bleeding. Dizziness, nausea, fatigue, headache and light
headedness have been reported occasionally and usually disappear
with adjustment of dose.
O
Progesterone
C21H30O2
Description
PROFEME® is a transdermal drug delivery system consisting of a white
oil-in-water cream intended for topical administration of progesterone
and contains dl-α- tocopherol acetate (vitamin E), almond oil and
macadamia oil formulated to optimise systemic absorption of the
active ingredient. Also contains cetomacrogol 1000, cetostearyl
alcohol, butylated hydroxytoluene, propyl hydroxybenzoate, citric
acid, methyl hydroxybenzoate, triethanolamine, carbomer 940, B&J
Phenonip® and purified water. PROFEME® contains the naturally
occurring hormone progesterone.
Pharmacology
Progesterone is secreted primarily from the corpus luteum of the
ovary during the latter half of the menstrual cycle. Progesterone is
formed from steroid precursors in the ovary, testes, adrenal cortex
and placenta. Lutenizing hormone (LH) stimulates the synthesis and
secretion of progesterone from the corpus luteum. Progesterone is
multifactorial in its actions. Maintenance of a secretory endometrium,
precursor to steroid synthesis and a host of intrinsic biological
properties make progesterone a hormone vital in providing a
balance to estradiol, the estrogenic hormone secreted by the ovary.
Progesterone has minimal estrogenic and androgenic activity. Orally
administered progesterone is rapidly metabolised by the liver and the
first-pass effect is extremely high. The hormone is reduced to inactive
metabolites pregnanedione, pregnenadone and pregnanediol in the
liver, conjugated with glucuronic acid, then excreted in the bile and
urine. Transdermal absorption of progesterone avoids the first-pass
metabolism. Progesterone has a short plasma half-life of several
minutes. Progesterone is extremely lipophyllic and binds to plasma
protein carriers, cortisol binding globulin (CBG), sex hormone-binding
globulin (SHBG), red blood cellular membranes1,2 and fatty tissue.
2-10% progesterone circulates unbound through plasma.
Progesterone administration achieves improvement in lipid and
lipoprotein profiles and when combined with estrogen therapies
indicates no increased risk of endometrial hyperplasia3, 4 and may
prevent breast epithelial hyperplasia5.
Indications
PROFEME® is indicated in progesterone-deficient conditions.
Progesterone deficiency is associated with natural or surgical
menopause, premenstrual syndrome (PMS), breast cancer, ovarian
cysts, uterine fibroids, endometrial hyperplasia and associated
estrogen-dependent malignancies, fibrocystic breasts, post-patrum
depression, repeat first-term miscarriages and endometriosis.
PROFEME® is not a substitute for estrogen replacement therapy.
Use In Pregnancy
Progesterone is the hormone essential for promotion and maintenance
of pregnancy. Ovarian output of progesterone in the non-pregnant
state is 25-30mg daily during the luteal phase. The placental output
during the third Trimester of pregnancy is 350-400 mg per day.
Whereas progestagens are contraindicated in pregnancy, progesterone
exhibits no adverse effects on the fetus.
Drug Interaction
Thyroid stimulating agents
Potential interaction exists in patients using thyroid supplementation.
Progesterone may cause a potentiation of thyroxine’s effects leading to
hyperthyroidism. Normal T3 and T4 levels with elevated TSH suggests
impaired thyroid hormone activity rather than insufficiency. Periodical
TSH testing should be adopted on initiation of progesterone treatment
in these patients.
Dosage And Administration
General considerations
A) Distribution: Maximum absorption is achieved by using PROFEME®
over a large skin area. The optimal skin sites to apply PROFEME®
progesterone cream are to the inner aspects of the arms and the upper
thigh. Other areas suitable for use include the abdomen and upper
chest/neck.
Progesterone is first absorbed into the subcutaneous fat layer then
passively diffuses throughout the body via the circulation. The rate
at which this is achieved is dependant on the amount of body fat.
In general most significant physiological results are not experienced
by patients until the fourth to sixth week of usage. In women using
estrogen supplements the initial effect of progesterone is to sensitise
estrogene receptors. A reduction in estrogen dosage may be required
should breast swelling and tenderness, fluid retention or scant bleeding
result.
WARNING: To date, PROFEME® cream has not been shown to be
protective against estrogen-induced endometrical hyperplasia.
Caution should be exercised and patients monitored if combination
therapy is to be initiated.
In peri-menopausal women with irregular menstrual flows the addition
of PROFEME® may result in a return of menses. This may lead to the
conclusion that progesterone caused the menses when in fact estrogen
created the endometrial proliferation. This effect is not abnormal when
starting PROFEME® and there is no reason to cease use of PROFEME®.
PROFEME® 3.2% PI
ProFeme®
ProFeme® 10
10
Cream containing 10% w/v (100mg/mL) Progesterone B.P. (Prog -4 -ene - 3.20 dione)
Perimenopausal women (including moderate heavy bleeding,
uterine fibroids and mild endometriosis).
Apply 0.3ml of PROFEME® 10% cream via measured applicator
(30mg progesterone) daily or in divided doses from day 12-26 of each
menstrual cycle. If a menstrual period starts prior to day 26 cease
using PROFEME® and consider the first day of bleeding as Day 1 of
the new cycle. This is a common occurrence when initiating treatment
in perimenopausal women and should be considered a sign that the
treatment is having a positive effect. Symptoms abate in 2nd or 3rd
month of use. Where symptoms are more severe or unresponsive
increase the dose to 100- 200mg (1-2mL daily).
Premenstrual syndrome (PMS).
Apply 0.3ml of PROFEME® 10% cream via measured applicator
(30mg progesterone) daily or in divided doses from day 12-26 of each
menstrual cycle. Significant alterations to this dosage may be made to
achieve a crescendo effect 4-5 days prior to menses. Symptoms abate
in 2nd or 3rd month of use.
Contraindications
Composition Active: Progesterone B.P.
Chemical Name: Prog -4 -ene - 3.20 dione
Molecular Weight: 314.47
CAS: 57-83-0
Progesterone should not be used by women with any of the following
conditions:
CH3
C=O
PROFEME® 10% CMI
•
•
•
•
•
Severe liver disease ie. cholestatic jaundice, Rotor syndrome or
Dubin-Johnson syndrome
Any unexplained abnormal vaginal bleeding
History of herpes gestationis
Jaundice of pregnancy
Known sensitivity to PROFEME® cream or any of its individual
components
Adverse Reactions
Because PROFEME® contains the hormone identical to that produced
by the human ovary side effects are usually minimal. If experienced
these may include breast tenderness and swelling, fluid retention or
slight vaginal bleeding. Dizziness, nausea, fatigue, headache and light
headedness have been reported occasionally and usually disappear
with adjustment of dose.
O
Progesterone
C21H30O2
Description
Where to apply PROFEME® cream?
Prior to using PROFEME®
PROFEME® cream should not be used if you are allergic to
progesterone, or any of the ingredients contained within PROFEME®.
These are listed at the end of this leaflet. This product contains
almond oil and macadamia nut oil. Do not use PROFEME® if you
have kidney disease, liver disease, unexplained abnormal vaginal
bleeding or herpes during pregnancy (herpes gestationis). Check with
your doctor or pharmacist if you are unsure about whether you have
any of these conditions before using PROFEME®. If you are taking
other medications check with your doctor or pharmacist before using
PROFEME®. PROFEME® is best applied to the inner forearm or upper
thigh. The area should be clean and dry.
No perfume, deodorant or moisturising creams or gels should be used
on the area because this may interfere with PROFEME® from being
absorbed.
0.5
What PROFEME® is used for?
PROFEME® contains the active ingredient progesterone.
This form of progesterone is identical to the progesterone produced by
the ovaries of women.
Progesterone plays an important role in the menstrual cycle,
reproduction, hormone production, mood, fluid balance, metabolism,
energy levels and well-being in women.
Where women suffer from a deficiency of progesterone one or more
of these areas may be affected and PROFEME® provides progesterone
to address this deficiency. The skin readily absorbs progesterone
and PROFEME® is a clean, simple and effective means of getting
progesterone into the body.
Contraindications
Composition Active: Progesterone B.P.
Chemical Name: Prog -4 -ene - 3.20 dione
Molecular Weight: 314.47
CAS: 57-83-0
PRODUCT INFORMATION
applicator into the open nozzle of PROFEME® cream so that the nozzle
and the shoulder of the applicator are in contact. GENTLY squeeze
the base of the PROFEME® tube until cream reaches the open nozzle
of the tube. At the same time slowly withdraw the plunger of the
applicator. The cream will flow into the barrel of the applicator. Fill to
the required dose. For example: a 1ml dose of PROFEME 10% (100mg
progesterone) needs the flat part of the plunger level with the 1ml
mark. If there are any air bubbles in the measured dose fill slightly
past the required dose mark then depress the plunger so that the
excess cream flows back into the tube. Stop at the required dose mark.
Remove the applicator from the nozzle of the tube and replace the cap
firmly on the tube. Depress the plunger of the applicator containing the
dose of PROFEME® directly onto the skin (inner arm or upper thigh).
Massage the cream into the area until absorbed. Rinse the applicator in
warm water after use and replace in box with PROFEME® progesterone
cream ready for the next day’s application. Each 1ml of PROFEME® 10%
contains 100mg of progesterone.
ml
What is in this leaflet?
This leaflet answers some of the common questions about PROFEME®.
It does not contain all the available information. It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
possible risks of you using PROFEME® against the benefits it can have
for you.
If you have any concerns about using PROFEME® talk to your doctor or
pharmacist. Keep this leaflet with the medicine. You may need to read
it again.
ProFeme®
3.2
PRODUCT INFORMATION
Measuring the correct dose of PROFEME® Cream
A measuring applicator (syringe style) in a sealed sleeve is enclosed in
the PROFEME® box. The dose of PROFEME® is measured in millilitres.
The applicator is marked with 0.5ml graduations for dosing accuracy.
Your doctor will have determined which dose is appropriate for you.
To measure the correct dose of cream insert the tip of the applicator
into the open nozzle of PROFEME® cream so that the nozzle and
the shoulder of the applicator are in contact. GENTLY squeeze the
base of the PROFEME® tube until cream reaches the open nozzle
of the tube. At the same time slowly withdraw the plunger of the
applicator. The cream will flow into the barrel of the applicator. Fill
to the required dose. For example: a 1ml dose of PROFEME® 3.2%
(32mg progesterone) needs the flat part of the plunger level with the
1ml mark. If there are any air bubbles in the measured dose fill slightly
past the required dose mark then depress the plunger so that the
excess cream flows back into the tube. Stop at the required dose mark.
Remove the applicator from the nozzle of the tube and replace the cap
firmly on the tube. Depress the plunger of the applicator containing the
dose of PROFEME® directly onto the skin (inner arm or upper thigh).
Massage the cream into the area until absorbed. Rinse the applicator in
warm water after use and replace in box with PROFEME® progesterone
cream ready for the next day’s application. Each 1ml of PROFEME®
3.2% contains 32mg of progesterone.
ml
What is in this leaflet?
This leaflet answers some of the common questions about PROFEME®.
It does not contain all the available information. It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
possible risks of you using PROFEME® against the benefits it can have
for you.
If you have any concerns about using PROFEME® talk to your doctor or
pharmacist. Keep this leaflet with the medicine. You may need to read
it again.
ProFeme® 3.2
Cream containing 3.2% w/v (32mg/mL) Progesterone B.P. (Prog -4 -ene - 3.20 dione)
CONSUMER MEDICINE INFORMATION
PROFEME® is a transdermal drug delivery system consisting of a white
oil-in-water cream intended for topical administration of progesterone
and contains dl-α- tocopherol acetate (vitamin E), almond oil and
macadamia oil formulated to optimise systemic absorption of the
active ingredient. Also contains cetomacrogol 1000, cetostearyl
alcohol, butylated hydroxytoluene, propyl hydroxybenzoate, citric
acid, methyl hydroxybenzoate, triethanolamine, carbomer 940, B&J
Phenonip® and purified water. PROFEME® contains the naturally
occurring hormone progesterone.
Pharmacology
Progesterone is secreted primarily from the corpus luteum of the
ovary during the latter half of the menstrual cycle. Progesterone is
formed from steroid precursors in the ovary, testes, adrenal cortex
and placenta. Lutenizing hormone (LH) stimulates the synthesis and
secretion of progesterone from the corpus luteum. Progesterone is
multifactorial in its actions. Maintenance of a secretory endometrium,
precursor to steroid synthesis and a host of intrinsic biological
properties make progesterone a hormone vital in providing a
balance to estradiol, the estrogenic hormone secreted by the ovary.
Progesterone has minimal estrogenic and androgenic activity. Orally
administered progesterone is rapidly metabolised by the liver and the
first-pass effect is extremely high. The hormone is reduced to inactive
metabolites pregnanedione, pregnenadone and pregnanediol in the
liver, conjugated with glucuronic acid, then excreted in the bile and
urine. Transdermal absorption of progesterone avoids the first-pass
metabolism. Progesterone has a short plasma half-life of several
minutes. Progesterone is extremely lipophyllic and binds to plasma
protein carriers, cortisol binding globulin (CBG), sex hormone-binding
globulin (SHBG), red blood cellular membranes1,2 and fatty tissue.
2-10% progesterone circulates unbound through plasma.
Progesterone administration achieves improvement in lipid and
lipoprotein profiles and when combined with estrogen therapies
indicates no increased risk of endometrial hyperplasia3, 4 and may
prevent breast epithelial hyperplasia5.
Indications
PROFEME® is indicated in progesterone-deficient conditions.
Progesterone deficiency is associated with natural or surgical
menopause, premenstrual syndrome (PMS), breast cancer, ovarian
cysts, uterine fibroids, endometrial hyperplasia and associated
estrogen-dependent malignancies, fibrocystic breasts, post-patrum
depression, repeat first-term miscarriages and endometriosis.
PROFEME® is not a substitute for estrogen replacement therapy.
Use In Pregnancy
Progesterone is the hormone essential for promotion and maintenance
of pregnancy. Ovarian output of progesterone in the non-pregnant
state is 25-30mg daily during the luteal phase. The placental output
during the third Trimester of pregnancy is 350-400 mg per day.
Whereas progestagens are contraindicated in pregnancy, progesterone
exhibits no adverse effects on the fetus.
Drug Interaction
Thyroid stimulating agents
Potential interaction exists in patients using thyroid supplementation.
Progesterone may cause a potentiation of thyroxine’s effects leading to
hyperthyroidism. Normal T3 and T4 levels with elevated TSH suggests
impaired thyroid hormone activity rather than insufficiency. Periodical
TSH testing should be adopted on initiation of progesterone treatment
in these patients.
Dosage And Administration
General considerations
A) Distribution: Maximum absorption is achieved by using PROFEME®
over a large skin area. The optimal skin sites to apply PROFEME®
progesterone cream are to the inner aspects of the arms and the upper
thigh. Other areas suitable for use include the abdomen and upper
chest/neck.
Progesterone is first absorbed into the subcutaneous fat layer then
passively diffuses throughout the body via the circulation. The rate
at which this is achieved is dependant on the amount of body fat.
In general most significant physiological results are not experienced
by patients until the fourth to sixth week of usage. In women using
estrogen supplements the initial effect of progesterone is to sensitise
estrogene receptors. A reduction in estrogen dosage may be required
should breast swelling and tenderness, fluid retention or scant bleeding
result.
WARNING: To date, PROFEME® cream has not been shown to be
protective against estrogen-induced endometrical hyperplasia.
Caution should be exercised and patients monitored if combination
therapy is to be initiated.
In peri-menopausal women with irregular menstrual flows the addition
of PROFEME® may result in a return of menses. This may lead to the
conclusion that progesterone caused the menses when in fact estrogen
created the endometrial proliferation. This effect is not abnormal when
starting PROFEME® and there is no reason to cease use of PROFEME®.
PROFEME® 10% PI
31
Why is Pro-Feme® progesterone cream the best?
If one Googles “natural hormone cream”, “progesterone cream”
or “testosterone cream” there are dozens of products claiming to
be the “best” and “authentic” natural progesterone/testosterone
creams or gels. Just how does one determine which product is most
suited to his/her requirements? The following is an outline of basic
manufacturing processes to help you decide. The three quality
standards of natural progesterone cream are:
1. P
harmaceutical Grade: The manufacturer operates to international
standards of Good Manufacturing Practice (GMP). GMP means all
production processes are standardized and controlled from the time
the raw material is procured through to the expiry date printing on
the finished product. The Australian government, like the U.S. and
European regulators, enforces rigid government controls on the
manufacturing facility, its equipment, processes, and packaging.
PROFEME® natural progesterone creams are guaranteed stable,
effective, and potent and the world’s only pharmaceutical grade
progesterone cream. The final product has detailed documentation
and is backed by clinical trials that substantiate its therapeutic claims.
2. C
osmetic Grade: This is the quality sold over-the-counter in
drug, department and grocery stores. Cosmetic grade products
do not undergo the rigorous checking processes as is required
of pharmaceuticals. Often, brand-names have exactly the same
ingredients as generics, just with a different label. Cosmetic grade
products are allowed a high bacterial content, so their shelf-life is
very limited (usually 3 to 6 months). Cosmetic manufacturers are not
required to register their products with the government regulators
because cosmetic products do not require clinical trials to prove their
worth. Cosmetic grade production is a self-regulating industry.
3. C
ompounded Product: Natural health products from pharmacists,
herbalists, homeopaths, naturopaths, and practitioners of traditional
Indian and Chinese medicines are compounded. This means the
product is tailored to the patient’s individual needs in the delivery
32
system most desired. Pharmacists compound drugs that are not
commercially available, or in a different strength than that readily
available. A compounded product may be needed to make a drug
palatable. A compounded product may be needed if the patient reacts
to dyes, preservatives, and allergens found in commercial products.
Compounded products do not undergo any form of production
control, concentration, impurity, stability or efficacy testing. Safe shelflife is usually extremely short, if at all known. Compounded items are
time-consuming to make, so generally they are more expensive.
The only pharmaceutical grade natural hormone creams available
worldwide are those made by Lawley Pharmaceuticals, Australia.
Lawley
Pharmaceuticals
(www.lawleypharm.com.au)
makes
PROFEME® 3.2% and 10% progesterone cream for females,
ANDROFORTE® 2 and ANDROFORTE® 5 testosterone cream
for males, ANDROFEME® 1% testosterone cream for women and
NATRAGEN® estradiol cream for women.
PROFEME® progesterone creams are specifically targeted for use
in women with declined or lowered serum progesterone levels
due to genetic disorders, surgical or chemical interventions, underproduction by the ovaries or ageing. Applied topically to the skin,
PROFEME® Progesterone creams for women are the world’s only
clinically trialled and tested pharmaceutical grade progesterone
creams using natural bio-identical progesterone. PROFEME®
progesterone creams are listed with the Australian government
(AUST L 95334 / L 70886).
ANDROFORTE® 2 www.androforte.com
ANDROFORTE® 5 www.androforte.com
NATRAGEN® www.natragen.com
33
ANDROFORTE® 2, ANDROFORTE® 5 and ANDROFEME® are
testosterone creams specifically targeted for use in men and women
with declined or lowered serum testosterone levels due to genetic
disorders, neurological disorders, surgical or chemical interventions
or under-production by the testes or ovaries and/or adrenal glands.
Applied topically to the skin, ANDROFORTE® 2, ANDROFORTE®
5 and ANDROFEME® are the world’s only clinically trialled and
tested pharmaceutical grade testosterone creams using natural bioidentical testosterone.
ANDROFORTE® 2, ANDROFORTE® 5 and ANDROFEME®
testosterone creams are listed with the Australian government
(AUST L 166239 / AUST L 166238 and AUST L 169317 respectively).
NATRAGEN® estradiol cream for women is specifically for conditions
of estrogen deficiency conditions including short-term use for
menopausal symptoms not responsive to PRO-FEME® such as hot
flashes, night sweats, vaginal dryness and atrophy. (AUST L 169397)
34
About Lawley Pharmaceuticals
Lawley Pharmaceuticals is a privately owned pharmaceutical
company which focuses on the transdermal administration of the
naturally occurring hormones progesterone, testosterone and
estradiol. Founded in 1995 by pharmacist Michael Buckley, Lawley
Pharmaceuticals has grown to become a world leader in research
and development of transdermal hormone preparations.
The Lawley Pharmaceuticals portfolio of products include:
ANDROFEME® 1% testosterone cream for women
ANDROFORTE® 2% and ANDROFORTE® 5% testosterone cream for men
PROFEME® 3.2% and PROFEME® 10% progesterone cream for women
NATRAGEN® 0.2% estradiol cream for women
35
Our Mission Statement
Lawley Pharmaceuticals (www.lawleypharm.com.au) strives to
provide the optimal delivery systems for the administration of
naturally occurring hormones to counter endocrine deficiency
states.
Our philosophy is based on the principle to use a bio-identical
hormone in preference to a synthetic hormone analogue (when a
viable clinical option) and to advance areas of clinical research using
natural hormones.
Our goal is to establish, through evidence-based medical research,
naturally occurring hormones as cornerstone treatments for
diseases such as breast cancer, infertility, first-term miscarriage,
male hypogonadism, post partum depression and endometriosis.
Lawley Pharmaceuticals has established strong links with centres
of medical research excellence around the world and continues to
push the boundaries of medical research.
Completed Clinical Studies
1. E
ffect of sequential transdermal progesterone cream on endometrium,
bleeding pattern, and plasma progesterone and salivary progesterone
levels in postmenopausal women. Wren BG et al. Climacteric 2000
3:155–160.
2. D
istribution and metabolism of topically applied progesterone in a
rat model. Waddell B and O’Leary PJ. J Ster Biochem & Mol Biol. 80
(2002) 449–455.
3. P
lasma and saliva concentrations of progesterone in pre- and
postmenopausal women after topical application of progesterone
cream. O’Leary PJ et al. Presented at the Annual Congress of the
Australian Menopause Society held in Perth, Australia in October 1997
4. L ong-term pharmacokinetics and clinical efficacy of
ANDROMEN®FORTE 5% cream for androgen replacement in
36
hypogonadal men. Handelsman DJ et al. ANZAC Research Institute,
Department of Andrology, Concord Hospital, Sydney, 2004.
5. T
ransdermal testosterone therapy improves well-being, mood, and
sexual function in premenopausal women. Goldstat R et al. Menopause
2003; 10 (5): 390-398.
6. T
he pharmacokinetics pilot study of ANDROFEME® 1% testosterone
cream following two-week, once-daily application in testosterone
deficient women. Eden JA et al. Presented at the 4th Annual Congress
of the Australasian Menopause Society held in Adelaide 5-7th
November 2000.
7. A
double-blind, randomized, placebo-controlled trial of the effect
of testosterone cream on the sexual motivation of menopausal
hysterectomized women with hypoactive sexual desire disorder. ElHage et al Climacteric 2007; 10: 335–343.
8. P
harmacokinetics Of Andromen Forte 5% Cream: A Dose Finding
Study. Kelleher S et al. ANZAC Research Institute, Department of
Andrology, Concord Hospital, Sydney, 2002.
Internet Education Reference Sites
ANDROFORTE www.androforte.com
ANDROFEME www.androfeme.com
PROFEME www.profeme.com
NATRAGEN www.natragen.com
HORMONE SOLUTIONS www.hormonesolutions.com.au
HORMONE SOLUTIONS www.hormonesolutions.com
ANDROPAUSE www.understandingandropause.com
ANOVULATION www.understandinganovulation.com
BENIGN BREAST DISEASE www.understandingbenignbreastdisease.com
BREAST DISEASE www.understandingbreastdisease.com
BREAST DISORDERS www.understandingbreastdisorders.com
CASTRATION www.understandingcastration.com
37
DYSFUNCTIONAL UTERINE BLEEDING
www.understandingdysfunctionaluterinebleeding.com
DYSMENORRHEA www.understandingdysmenorrhea.com
DYSPAREUNIA www.understandingdyspareunia.com
EARLY MENOPAUSE www.understandingearlymenopause.com
ESTROGEN DOMINANCE www.understandingestrogendominance.com
FEMALE SEXUAL DYSFUNCTION
FIBROCYSTIC BREAST DISEASE
www.understandingfibrocysticbreastdisease.com
FSD www.understandingfsd.com
GYNECOMASTIA www.understandinggynecomastia.com
HEAVY PERIODS www.understandingheavyperiods.com
HORMONE MIGRAINE www.understandinghormonemigraine.com
HYPOGONADISM www.understandinghypogonadism.com
HYSTERECTOMY www.understandinghysterectomy.com
INFERTILITY www.understandinginfertility.biz
IRREGULAR PERIODS www.understandingirregularperiods.com
KLINEFELTER SYNDROME www.understandingklinefeltersyndrome.com
LIBIDO www.understandinglibido.com
LOW LIBIDO www.understandinglowlibido.com
LOW TESTOSTERONE www.understandinglowtestosterone.com
MENOPAUSE www.understandingmenopause.biz
MENORRHAGIA www.understandingmenorrhagia.com
MISCARRIAGE www.understandingmiscarriage.com
MOOD CHANGES www.understandingmoodchanges.com
38
OVARIAN CYSTS www.understandingovariancysts.com
PCOS www.understandingpcos.com
PERIMENOPAUSE www.understandingperimenopause.com
PMDD www.understandingpmdd.com
POLYCYSTIC OVARIAN SYNDROME
www.understandingpolycysticovariansyndrome.com
POST NATAL DEPRESSION www.understandingpostnataldepression.com
POST PARTUM DEPRESSION
www.understandingpostpartumdepression.com
PREGNANCY www.understandingpregnancy.biz
PREMENSTRUAL SYNDROME
39
Copyright Information
© Lawley Pharmaceuticals 2010
This publication is copyright. Other than for the purposes of and
subject to the Copyright Act, no part of it may in any form or by
any means (electronic, mechanical, microcopying, photocopying,
recording or otherwise) be reproduced, stored in a retrieval system
or transmitted without prior written permission.
Enquiries should be addressed to:
Lawley Pharmaceuticals, 2/15 Harrogate St,
West Leederville 6007, WA Australia
This brochure is presented by
Lawley Pharmaceuticals
2/15 Harrogate St, West Leederville 6007, WA Australia
T. +61 (0)8 9388 0096 or 1800 627 506
F. +61 (0)8 9388 0098
E. [email protected]
W. www.lawleypharm.com.au
USA and Canada Toll free phone: 1-800-961-7813
Toll free fax: 1-800-961-7650
LAWLEY
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