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Brief Title: A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
Official Title: A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
Study ID: NCT00152256
Brief Summary: The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
Detailed Description: No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Name: Medical Director
Affiliation: Abbott
Role: STUDY_CHAIR