The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Berlex Laboratories
Approval Status: Approved June 1999
Treatment for: Obstetrics/Gynecology
General Information
The ClimaraŽ system provides systemic estrogen replacement therapy by releasing
17b-estradiol, the major estrogenic hormone secreted by the human ovary. Transdermal administration of ClimaraŽ produces mean serum concentrations of estradiol
comparable to those produced by premenopausal women in the early follicular phase of the
ovulatory cycle.
The adhesive side of the ClimaraŽ system should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. The ClimaraŽ system should not be applied to the breasts. The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub and remove the system.
Applications to areas where sitting would dislodge the system should be avoided. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges. If the system lifts, apply pressure to maintain adhesion. In the unlikely event that a system should fall off, a new system should be applied for the remainder of the 7-day dosing interval. Only one system should be worn at any one time during the 7-day dosing interval.
Side Effects
The most commonly reported adverse reaction to the ClimaraŽ system in clinical trials was skin irritation at the application site. In two well-controlled clinical studies, the overall rate of
discontinuation due to skin irritation at the application site was 6.8%: 7.9% for the 12.5 cm2
system and 5.3% for the 25.0 cm2 system compared with 11.5% for the placebo system. In a
3-week comparative skin irritation study with the EstradermŽ system, in 95 subjects, no
statistically significant differences in irritation were observed. Some degree of irritation at the
end of week three was seen in 25% of EstradermŽ and 31% of ClimaraŽ subjects. Clinically
significant irritation (mild erythema associated with symptoms or moderate to severe erythema)
was evident at the end of week three in 11% of EstradermŽ and 9% of ClimaraŽ subjects.
Estrogens should not be used in individuals with any of the following conditions:
- Known or suspected pregnancy (see Boxed Warning). Estrogens may cause fetal harm when administered to a pregnant woman.
- Undiagnosed abnormal genital bleeding.
- Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.
- Known or suspected estrogen-dependent neoplasia.
- Active thrombophlebitis or thromboembolic disorders.
Additional Information
(Not every estrogen drug is approved for every use listed in this section. If you want to know which of these possible uses are approved for the medicine prescribed for you, ask your doctor or pharmacist to show you the professional labeling. You can also look up the specific estrogen product in a book called the "Physician's Desk Reference", which is available in many book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name versions.)
To reduce moderate or severe menopausal symptoms.
Estrogens are hormones made by the ovaries of normal women. Between ages 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels which causes the "change of life" or menopause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden drop in estrogen levels causes "surgical menopause". When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense
episodes of heat and sweating ("hot flashes" or "hot flushes"). Using estrogen drugs can
help the body adjust to lower estrogen levels and reduce these symptoms. Most women
have only mild menopausal symptoms or none at all and do not need to use estrogen drugs
for these symptoms. Others may need to take estrogens for a few months while their bodies
adjust to lower estrogen levels. The majority of women do not need estrogen replacement
for longer than six months for these symptoms.
To treat vulval and vaginal atrophy (itching, burning, dryness in or around the vagina,
difficulty or burning on urination) associated with menopause.
To treat certain conditions in which a young woman's ovaries do not produce enough
estrogen naturally.
To treat certain types of abnormal vaginal bleeding due to hormonal imbalance when
your doctor has found no serious cause of the bleeding.
To treat certain cancers in special situations, in men and women.
To prevent thinning of bones.
Osteoporosis is a thinning of the bones that makes them weaker and allows them to break
more easily. The bones of the spine, wrists and hips break most often in osteoporosis. Both
men and women start to lose bone mass after about age 40, but women lose bone mass
faster after the menopause. Using estrogens after the menopause slows down bone thinning
and may prevent bones from breaking. Lifelong adequate calcium intake, either in the diet
(such as dairy products) or by calcium supplements (to reach a total daily intake of 1000
milligrams per day before menopause or 1500 milligrams per day after menopause), may
help to prevent osteoporosis. Regular weight-bearing exercise (like walking and running
for an hour, two or three times a week) may also help to prevent osteoporosis. Before you
change your calcium intake or exercise habits, it is important to discuss these lifestyle
changes with your doctor to find out if they are safe for you.
Since estrogen use has some risks, only women who are likely to develop osteoporosis
should use estrogens for prevention. Women who are likely to develop osteoporosis often
have the following characteristics: white or Asian race, slim, cigarette smokers, and a
family history of osteoporosis in a mother, sister, or aunt. Women who have relatively
early menopause, often because their ovaries were removed during an operation ("surgical
menopause"), are more likely to develop osteoporosis than women whose menopause
happens at the average age.
