NCT00958893

An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed description

This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	25 mg Proellex	one 25 mg capsules

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-08-13
• Last updated: 2014-08-25
• Results posted: 2014-08-25

Locations

1 site across 1 country: United States