Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
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Ages Eligible for Study:
45 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Hysterectomized or non-hysterectomized
Moderate or severe vaginal dryness and soreness
Successful completion of the study VAG/PD/009/USA
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
Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days