Vivelle (estradiol transdermal system)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved March 1996

Specific Treatments:

menopausal symptoms

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General Information

Vivelle is an estrogen skin patch that has been approved as a treatment for moderate-to-severe vasomotor menopausal symptoms, including hot flashes, night sweats, and vaginal dryness. This new treatment option is available in four dosage strengths.

Vivelle uses a matrix technology in which the active ingredient, 17-beta estradiol, the primary estrogen produced by the ovaries, is embedded in the adhesive. This design allows for a patch that is small, thin, flexible, and translucent. Vivelle delivers smooth, consistent levels of estradiol through the skin directly into the bloodstream. The patch is applied twice weekly and can be worn on either the buttocks or abdomen. Contact with water when bathing, swimming, or showering will not affect the patch.

Side Effects

Common side effects of the patch are skin irritation and itching at the application site, which, in most cases, are mild. Headache, breast tenderness and fluid retention also have been reported with estrogen use.

Additional Information

The first estrogen skin patch for the treatment of menopausal symptoms was Estraderm (estradiol transdermal system), which was introduced by Ciba Pharmaceuticals in 1986. Estraderm is indicated for the relief of moderate-to-severe vasomotor symptoms and the prevention of postmenopausal osteoporosis. Vivelle is not indicated for the prevention of postmenopausal osteoporosis; clinical trials to assess the efficacy of Vivelle for this indication are underway.

Estrogen replacement therapy is not advisable for some women. When considering an estrogen therapy, it is important to balance the risks against the benefits. For example, pregnant women should not use estrogen therapy. Estrogen therapy has been associated with an increased risk of cancer of the uterus. Women should tell their doctors whether they have had cancer of the breast or uterus, unusual vaginal bleeding, abnormal blood clotting, or any cardiovascular disease.