Study of Asoprisnil in the Treatment of Uterine Fibroids.

• Status: Completed
• Trial end date: 2007-02-01
• 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 active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment

• Otherwise in good health

• Premenopausal based on Estrogen and FSH levels

• Adequate endometrial biopsy with no significant histological disorder

• Agrees to use double-barrier method of contraception

Exclusion Criteria:

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

• History of a blood-clotting disorder

• History of osteoporosis requiring treatment

• Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study

• Hemoglobin < 8.0 g/dL

• Endometrial thickness ≥ 19 mm