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3/24/2003

Vaginal Estrogen Ring Approved for Menopausal Symptoms

Cheryl A. Thompson

Femring, an intravaginal product that delivers a steady dose of estrogen for three months, has been approved for the U.S. market, Galen Holdings PLC announced Friday.

The estradiol acetate vaginal ring is indicated for the treatment of menopause-related hot flashes and vaginal symptoms and designed for self-insertion by patients, the company said. According to documentation for the company's Menoring, a product similar to Femring but marketed in the United Kingdom, the estradiol acetate vaginal ring is for use only by women who have had all or part of their uterus removed.

During studies of the product, the company said, the most frequently reported adverse effects were headache, vaginal bleeding inbetween menstrual periods, vaginal candidiasis, and breast tenderness.

The estrogen delivery device should not be used in women with abnormal vaginal bleeding that has not been diagnosed; suspected, known, or a history of breast cancer; a suspected or known estrogen-depended cancer; active deep vein thrombosis or pulmonary embolism or a history of one of those conditions; or active or recent arterial thromboembolic disease.

Galen said it plans to make Femring available in June. The product will be available in two strengths, delivering 50 or 100 mcg of estradiol daily for three months.