Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
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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
Actual Study Start Date :
August 31, 1994
Actual Primary Completion Date :
November 30, 1995
Actual Study Completion Date :
November 30, 1995
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Ages Eligible for Study:
45 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness
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
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