Vivelle (estradiol transdermal system)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
For the prevention of osteoporosis and treatment of other menopausal symptoms
General Information
Vivelle provides estrogen replacement therapy by releasing
estradiol through a controlled release patch. Estradiol is an
estrogenic hormone secreted by the human ovary. Estrogen levels
decrease after menopause, which may in turn increase the risk of
osteoporosis. Vivelle works to counteract this loss through the
continual release of estradiol. The hormone is contained in the
adhesive of the patch, and the system is designed to release
estradiol upon application to the skin.
Clinical Results
In two controlled clinical trials of 356 subjects, two dose
levels of Vivelle were tested. The 0.075 and 0.1 mg doses were
superior to a placebo in relieving vasomotor symptoms at week four,
and maintained efficacy through weeks eight and 12 of treatment. An
additional 12-week placebo-controlled study in 255 patients was
performed to test the lowest dose of 0.0375 mg. The 0.0375 mg dose
was also superior to a placebo in reducing both the frequency and
severity of vasomotor symptoms.
The Vivelle system's possible benefits in the prevention of
postmenopausal osteoporosis have also been examined. A 2-year
double-blind, randomized, placebo-controlled parallel group study
was conducted with a total of 261 individuals. The enrolled group
consisted of hysterectomized (161) and non-hysterectomized (100),
surgically or naturally menopausal women (within 5 years of
menopause), with no evidence of osteoporosis. There was an increase
in bone mineral density (BMD) of the AP lumbar spine in all Vivelle
groups, compared to a decrease in AP lumbar spine BMD observed in
placebo patients. All Vivelle doses were significantly superior to
a placebo at all time points with the exception of Vivelle 0.05
mg/day at 6 months. The highest dose of Vivelle was superior to the
three lower doses. (from FDA Label)
Side Effects
Adverse reactions associated with Vivelle include (but are not
limited to) the following:
- Headache
- Skin irritation at the application site
- Nausea
- Breast tenderness or enlargement
- Back pain
- Vaginal spotting or bleeding
Additionally, estrogens should not be used by individuals with
any of the following conditions:
- Known or suspected pregnancy
- Undiagnosed abnormal genital bleeding
- Known or suspected breast cancer
Mechanism of Action
Vivelle provides systemic estrogen replacement therapy through
the release of estradiol. Although circulating estrogens exist in a
dynamic equilibrium of metabolic interconversions, estradiol is the
principal intracellular human estrogen and is substantially more
potent than its metabolites, estrone and estriol, at the receptor
level. The primary source of estrogen in normally cycling adult
women is the ovarian follicle. After menopause, most endogenous
estrogen is produced by conversion of androstenedione, secreted by
the adrenal cortex, to estrone by peripheral tissues. Thus, estrone
and the sulfate conjugated form, estrone sulfate, are the most
abundant circulating estrogens in postmenopausal women.
Circulating estrogens modulate the pituitary secretion of the
gonadotropins, luteinizing hormone (LH) and follicle stimulating
hormone (FSH), through a negative feedback mechanism and estrogen
therapy acts to reduce the elevated levels of these hormones seen
in postmenopausal women. (from FDA Label)
Additional Information
For more information on osteoporosis, please visit the web site
of The
Endocrine Society. This site provides fact sheets for patients
on a variety of topics.