Approximately 75% of menopausal women experience such symptoms as vaginal dryness and temperature fluctuations (“hot flushes”). Many women who have taken estrogen tablets or patches still experience vaginal symptoms. The FDA has approved an estradiol acetate vaginal ring (Femring™, Galen), the first vaginal estrogen product that is indicated to treat both the hot flushes and the vaginal symptoms associated with menopause. Galen plans to introduce the drug into the U.S. market in June 2003.
The ring includes a steady three-month supply of generic estradiol in just one dose. In clinical trials, women reported that they found the ring convenient, effective, and easy to use. The women had few problems inserting or removing the ring, and the most of them reported they were comfortable and not aware of wearing it. Most of the women expressed the desire that health care professionals offer the ring when discussing hormone therapy options with their patients.
The drug will be available in two strengths, 0.05 mg/day or 0.1 mg/day.
The most frequently reported adverse events in clinical trials were headache, bleeding between menstrual periods, vaginal candidiasis, and breast tenderness. These events are commonly observed with all estrogen products.
Estrogens should not be used in any of the following situations:
- undiagnosed abnormal genital bleeding
- known or suspected cancer of the breast or a history of the disease
- known or suspected estrogen-dependent neoplasia
- active deep vein thrombosis, pulmonary embolism, or a history of these conditions
- active or recent arterial thrombo-embolic disease
- known hypersensitivity to any of the drug’s compounds
Estrogens, with or without progestins, should not be used to prevent cardiovascular disease. Estrogens have been reported to increase the risk of endo-metrial carcinoma.