The FDA has approved a 10 mg formulation of Vagifem (estradiol vaginal tablets, from Novo Nordisk) for the treatment of atrophic vaginitis due to menopause. This approval is based on clinical data from a 52-week, multicenter, randomized, placebo-controlled trial that found statistically significant improvement with Vagifem 10 mg compared with placebo after 12 weeks of treatment in the relief of bothersome symptoms (e.g., vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, pain with urination, painful intercourse, and vaginal bleeding associated with intercourse) and in the correction of important biological markers (vaginal pH, vaginal maturation index) to levels seen in nonmenopausal women.

Vagifem is already available as a 25 mg vaginal tablet.

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