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

Phase 2

Terminated

• Conditions: Uterine Fibroids
• Interventions: Drug: 25 mg Proellex

• Registration Number: NCT00958893
• Lead Sponsor: Repros Therapeutics Inc.

Brief 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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Results First Submitted: 2014-06-25
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-08
• Last Update Submitted: 2014-08-08
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria

• All other subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
25 mg Proellex	25 mg Proellex	25 mg Proellex daily

Primary Outcome Measures

Name	Time	Method
To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.	three 4 month cycles separated by off-drug intervals

Trial Locations

Locations (1)

Advances in Health, Inc.; 🇺🇸 Houston,, Texas, United States