A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• Premenopausal women

• History of regular menstrual cycles (21-42 days)

• Diagnosis of uterine fibroid(s)

• Abnormal vaginal bleeding associated with uterine fibroids

• Otherwise in good health

• Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

Exclusion Criteria:

• Less than 3 months postpartum and post-lactation

• Previous myomectomy within 1 year

• Any abnormal lab or procedure result the study-doctor considers important

• Severe reaction(s) to or are currently using any hormone therapy

• History of osteoporosis or other bone disease