A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• Women between 18 and 49 years of age

• Diagnosis of either 1 or more uterine fibroids

• History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

• Any abnormal lab result the study-doctor considers significant

• History of severe reaction to or current use of hormone therapy

• History of osteoporosis or other bone disease

• History of uterine artery embolization, cryomyolysis, or electrical myolysis

• Subject currently breast feeding

• Hemoglobin < 8 g/dL at baseline