A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

• Status: Completed
• Trial end date: 2001-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

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

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria:

• Completed dosing and Day 84 procedures at sites in study M99-144

• No interruption of dosing

• Otherwise continued good health

Exclusion Criteria:

• Any abnormal lab result the study-doctor considers significant

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

• History of alcohol or drug abuse