NCT00156182

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

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

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.

Detailed description

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Asoprisnil	10mg Tablet, oral Daily for 6 months

Timeline

• Start date: 2001-04-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2005-09-12
• Last updated: 2009-03-04