Safety of Treatment of Uterine Fibroids With Asoprisnil

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

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

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment

• Otherwise good health

• Premenopausal based on Estrogen and Follicle Stimulating Hormone levels

• Agrees to double-barrier method of contraception

• Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

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

• History of a blood-clotting disorder

• Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away

• Significant gynecological disorder, such as endometrial polyp