Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00958412
• Collaborator: (none)
• Enrollment: 18
• Locations: 8
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

ZPE-201 Extension of treatment

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Proellex®	Phase 2

Detailed Description

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
• Actual Study Start Date: Feb 28, 2009
• Actual Primary Completion Date: Aug 31, 2009
• Actual Study Completion Date: Aug 31, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proellex® 25 mg Proellex®	Drug: Proellex®; one (1) 25 mg capsule daily; Other Names: CDB-4124

Outcome Measures

Primary Outcome Measures

1. To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily [6 months]

   Number of participants who experienced 1 or more adverse event.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.

• Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria:

• All other subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Therapeutics, LLC	Tucson	Arizona	United States	85712
2	Medical Center for Clinical Research	San Diego	California	United States	92108
3	Compass Clinical Research	San Ramon	California	United States	94583
4	Comprehensive Clinical Trials	West Palm Beach	Florida	United States	33409
5	Physicians for Women	Cary	North Carolina	United States	27518
6	HWC Women's Research Center	Miamisburg	Ohio	United States	45322
7	Clinical Trials of Texas/Institute for Women's Health	San Antonio	Texas	United States	78229
8	Clinical Trials of Texas/Seven Oaks Women's Center	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Repros Therapeutics Inc.

Investigators

• Study Director: Anna Chan, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00958412
• Other Study ID Numbers: ZPE-201 EXT
• First Posted: Aug 13, 2009
• Last Update Posted: Feb 12, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Repros Therapeutics Inc.: Endometriosis; Pelvic pain; Oral progesterone blocker
• Additional relevant MeSH terms: Endometriosis

Study Results

Participant Flow

Arm/Group Title	Proellex
Arm/Group Description	Proellex: one (1) 25 mg capsule daily Study was terminated prematurely and no data is available
Period Title: Overall Study
STARTED	18
COMPLETED	0
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	Proellex®
Arm/Group Description	Proellex®: one (1) 25 mg capsule daily
Overall Participants	18
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	18 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Description	Number of participants who experienced 1 or more adverse event.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Proellex®
Arm/Group Description	Proellex®: one (1) 25 mg capsule daily
Measure Participants	18
Number [Participants]	16 88.9%

Adverse Events

Time Frame	6 months
Arm/Group Title	Proellex®
Arm/Group Description	Proellex®: one (1) 25 mg capsule daily No data available
All Cause Mortality
	Proellex®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Proellex®
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	Proellex®
	Affected / at Risk (%)	# Events
Total	16/18 (88.9%)
Cardiac disorders
Irregular Heart Beat	1/18 (5.6%)
Gastrointestinal disorders
left lower quadrant pain	1/18 (5.6%)
Right lower quadrant abdomen pain	1/18 (5.6%)
Immune system disorders
Seasonal Allergies	1/18 (5.6%)
Infections and infestations
Influenza	1/18 (5.6%)
sinus infection	1/18 (5.6%)
verruca vulgaris	1/18 (5.6%)
Yeast Infection	1/18 (5.6%)
Investigations
1.5 % decrease femur bone density	1/18 (5.6%)
abnormal labs	1/18 (5.6%)
Decrease in Bone mineral Density	2/18 (11.1%)
Decreased bone Mineral Density in the Lumbar Spine	2/18 (11.1%)
Elevated ALT	1/18 (5.6%)
Elevated AST	1/18 (5.6%)
Left hip bone mineral density decreased	1/18 (5.6%)
Lumbar Spine Bone Mineral Density Decreased	1/18 (5.6%)
weight gain	1/18 (5.6%)
Musculoskeletal and connective tissue disorders
joint pain	1/18 (5.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystic Left Ovary	1/18 (5.6%)
Left Cystic Ovary	1/18 (5.6%)
left ovarian complex cyst	2/18 (11.1%)
Right ovarian complex cyst	1/18 (5.6%)
right ovarian cyst 1.5cm	1/18 (5.6%)
Right Paraovarian cyst	1/18 (5.6%)
Nervous system disorders
Crying	1/18 (5.6%)
exacerbation migraine	1/18 (5.6%)
Mood Swings	2/18 (11.1%)
Psychiatric disorders
insomnia	1/18 (5.6%)
Anxiety	1/18 (5.6%)
Renal and urinary disorders
Hematuria	1/18 (5.6%)
Reproductive system and breast disorders
cervical tenderness	1/18 (5.6%)
Decreased Libido	1/18 (5.6%)
vaginal discharge	1/18 (5.6%)
sexual desire loss	1/18 (5.6%)
Skin and subcutaneous tissue disorders
skin rash	1/18 (5.6%)
Vascular disorders
Hot Flashes	4/18 (22.2%)

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