Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Inclusion Criteria:

• Generally healthy
• Postmenopausal
• Hysterectomized or non-hysterectomized
• Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

• Known, suspected, or past history of breast cancer
• Known, suspected, or past history of hormone-dependent tumor
• Genital bleeding of unknown etiology
• Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
• Vaginal infection
• Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
• Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
• History of treatment with diethylstilbestrol