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Bone and Cancer

Clinical Trials

FemPatch

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

Company:

Approval Status:

Approved December 1996

Specific Treatments:

menopausal symptoms

General Information

FemPatch has been approved for the treatment of menopausal symptoms. Using a low, .025 mg dose of 17 beta-estradiol (a natural form of estrogen) in a thin, flexible once-weekly patch, Fem Patch provides relief of vasomotor symptoms such as hot flashes and night sweats.

FemPatch treats moderate to severe vasomotor menopausal symptoms using a patented matrix system that delivers estradiol through the skin in a consistent, low dose, reaching maximum blood levels within 24 hours and then maintaining constant blood levels for seven days.

FemPatch is a translucent, skin-like, rectangular-shaped laminated matrix system composed of three distinct layers. The recommended starting dose of FemPatch, when initiating estrogen replacement therapy in the management of vasomotor symptoms of menopause, is one patch every seven days. The buttocks is the preferred site of FemPatch application.

As with other estrogen replacement therapies, FemPatch may not be suitable for all patients and should not be used by women with any known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis; or thromboembolic disorders.

Clinical Results

In clinical trials, FemPatch was shown to effectively reduce vasomotor symptoms by consistently delivering a nominal .025 mg dose of estradiol. Two independent, 12-week, double-blind, placebo-controlled studies conducted with 324 surgically or naturally menopausal women (a mean of 80 hot flashes per week and a range of 56-140 hot flashes per week), showed that FemPatch significantly reduced the number of hot flashes. By week 123, hot flash frequency decreased from 80 hot flashes to 13 per week--a reduction of 84%. Reduction of hot flashes was significant as early as week two in some treatment groups, and by week three in all treatment groups.

Side Effects

Clinical studies with FemPatch showed a low incidence of discontinuation due to skin effects (3%) or adhesion failure (less than 2%). Overall, discontinuation due to adverse events for FemPatch (2.8%) was comparable to placebo (2.8%). Side effects with FemPatch are similar to those seen with other estrogen replacement therapies. As with all estrogen products, there are possible common side effects such as: headache, nausea, abdominal cramps, fluid retention, irregular bleeding, breast tenderness, or increase or decrease in weight. Estrogens also have been reported to increase the risk of endometrial carcinoma in postmenopausal women.

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