Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Berlex Laboratories
Approval Status: Approved June 1999
Treatment Area: Obstetrics/Gynecology
The Climara® system provides systemic estrogen replacement
therapy by releasing 17b-estradiol, the major estrogenic hormone
secreted by the human ovary. Transdermal administration of Climara®
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 Climara® system should be placed on a
clean, dry area of the lower abdomen or the upper quadrant of the
buttock. The Climara® 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
The most commonly reported adverse reaction to the Climara®
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 Estraderm® 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 Estraderm® and 31% of Climara® 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 Estraderm® and 9% of Climara® subjects.
Estrogens should not be used in individuals with any of the
- 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.
(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
To reduce moderate or severe menopausal
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
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
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.