Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively

• Otherwise in good health

• Premenopausal based on Estrogen and FSH levels

• Agrees to use of 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

• Significant gynecological disorder such as confirmed endometrial polyp

• Hemoglobin < 8.0 g/dL

• 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.