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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958893
• Other study ID #: ZPU-003 Extension 2
• Status: Terminated
• Phase: Phase 2
• First received: August 11, 2009
• Last updated: August 8, 2014
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• All other subjects

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• 25 mg Proellex
one 25 mg capsules

Locations

Country	Name	City	State
United States	Advances in Health, Inc.	Houston,	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes