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最高研发阶段批准上市 |
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首次获批日期1960-11-18 |
A Randomized, Double-blind, Placebo-Controlled, Dose De-escalation Phase 2 Study of Various Doses of Ovestin in the Treatment of Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, dose-de-escalation study whose purpose is to establish the lowest efficacious dose. The first 40 subjects will be randomized 1:1:1:1 to either 500 mcg, 50 mcg, 10 mcg, or placebo. After four weeks of dosing with 500 mcg, vaginal pH, vaginal maturation index, and subject's most bothersome moderate to severe symptom will be assessed; the changes observed will be used as the benchmark for efficacy throughout the remainder of the study and select the next dose-level to be investigated. Subjects will be enrolled in small cohorts at various doses until the lowest effective dose is identified. Then, 1 to 2 doses and a placebo group will be expanded to enroll 70 subjects per treatment group.
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