TerminatedNCT00958412Updated Feb 12, 2019Results posted

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

A Phase 2 interventional study of Proellex® in Endometriosis, sponsored by Repros Therapeutics Inc.. Terminated at 8 sites in United States. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Repros Therapeutics Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

Repros stopped the study for safety and FDA put the study on hold for safety.

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Feb 2009, registered Aug 2009).

Phase: Phase 2
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years to 48 Years
Sex: Female

Study summary

ZPE-201 Extension of treatment

Read the 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.

Conditions studied

Endometriosis

Browse trials for

Endometriosis 901

Keywords

Endometriosis
Pelvic pain
Oral progesterone blocker

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 18 is below the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 48 Years
Sexes eligible: 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

Exclusion Criteria:

All other subjects

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Experimental
Proellex®
25 mg Proellex®
Drug: Proellex®

Interventions

DrugProellex®
one (1) 25 mg capsule daily
Also known as: CDB-4124

What researchers measure

Primary outcomes

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

Results

Posted Feb 12, 2019

Limitations and 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.

Participant flow

Participant flow — Overall Study
Milestone	Proellex
Started	18
Completed	0
Not completed	18
Withdrew: Study prematurely terminated	18

Outcome measures

PrimaryTo Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily

Number of participants who experienced 1 or more adverse event.

Time frame:: 6 months
Reported as:: Number · Participants

To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Participants	Proellex®
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily	16

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Proellex®	—	0/18 (0%)	16/18 (88.9%)

Most frequent other events

Showing 10 of 36

Most frequent other events
Event	Proellex®
Hot FlashesVascular disorders	4/18
Decrease in Bone mineral DensityInvestigations	2/18
Decreased bone Mineral Density in the Lumbar SpineInvestigations	2/18
left ovarian complex cystNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/18
Mood SwingsNervous system disorders	2/18
Seasonal AllergiesImmune system disorders	1/18
1.5 % decrease femur bone densityInvestigations	1/18
abnormal labsInvestigations	1/18
cervical tendernessReproductive system and breast disorders	1/18
CryingNervous system disorders	1/18

Baseline characteristics

A total of 18 participants were randomized; study prematurely terminated.

Age, Categorical
Age, Categorical(Participants)	Proellex®
<=18 years	0
Between 18 and 65 years	18
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Proellex®
Female	18
Male	0

Study locations

8 sites

Advanced Clinical Therapeutics, LLC
Tucson, Arizona 85712, United States
Medical Center for Clinical Research
San Diego, California 92108, United States
Compass Clinical Research
San Ramon, California 94583, United States
Comprehensive Clinical Trials
West Palm Beach, Florida 33409, United States
Physicians for Women
Cary, North Carolina 27518, United States
HWC Women's Research Center
Miamisburg, Ohio 45322, United States
Clinical Trials of Texas/Institute for Women's Health
San Antonio, Texas 78229, United States
Clinical Trials of Texas/Seven Oaks Women's Center
San Antonio, Texas 78229, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00958412
Lead sponsor: Repros Therapeutics Inc.
Responsible party: Sponsor
First posted: Aug 13, 2009
Start date: Feb 28, 2009
Primary completion: Aug 31, 2009
Completion: Aug 31, 2009
Results posted: Feb 12, 2019
Last update: Feb 12, 2019

Study contacts

Anna Chan

study director · Allergan

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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