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

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00958893
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Drug: 25 mg Proellex	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 25 mg Proellex 25 mg Proellex daily	Drug: 25 mg Proellex; one 25 mg capsules; Other Names: CDB-4124 Proellex

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• All other subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advances in Health, Inc.	Houston,	Texas	United States	77030

Sponsors and Collaborators

• Repros Therapeutics Inc.

Investigators

• Study Director: Andre van As, MD, PhD, Repros Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00958893
• Other Study ID Numbers: ZPU-003 Extension 2
• First Posted: Aug 13, 2009
• Last Update Posted: Aug 25, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Repros Therapeutics Inc.: Uterine fibroids
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Arm/Group Title	25 mg Proellex
Arm/Group Description	25 mg Proellex: one 25 mg capsules
Period Title: Overall Study
STARTED	4
COMPLETED	0
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	25 mg Proellex
Arm/Group Description	25 mg Proellex daily
Overall Participants	0
Age (Count of Participants)
Sex: Female, Male (Count of Participants)
Region of Enrollment (participants) [Number]

Outcome Measures

1. Primary Outcome

Title	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.
Time Frame	three 4 month cycles separated by off-drug intervals

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	25 mg Proellex
Arm/Group Description	25 mg Proellex: one 25 mg capsules
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	No adverse event data is available.
Arm/Group Title	25 mg Proellex
Arm/Group Description	25 mg Proellex: one 25 mg capsules
All Cause Mortality
	25 mg Proellex
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	25 mg Proellex
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	25 mg Proellex
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights