Study Stopped
Clinical hold for safety
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
1 other identifier
interventional
67
1 country
17
Brief Summary
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 7, 2007
CompletedFirst Posted
Study publicly available on registry
November 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
August 25, 2014
CompletedAugust 25, 2014
August 1, 2014
1.5 years
November 7, 2007
June 24, 2014
August 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
4 months
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
4 months
Secondary Outcomes (4)
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
monthly
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
days
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
days
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
days
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo once daily
25 mg
EXPERIMENTALProellex 25 mg once daily
50 mg
EXPERIMENTALProellex 50 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Premenopausal women aged 18-48 inclusive
- Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
- Clinical symptoms of endometriosis for at least the past three (3) months
- Endometriosis symptoms
- Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
- Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
You may not qualify if:
- Six (6) months or more without a menstrual period, or
- Prior hysterectomy or
- Prior bilateral oophorectomy
- Diagnosis of osteopenia
- Present history or condition that causes non-endometriosis-related dyspareunia
- Presence of excessive bleeding or menorrhagia
- Abnormal screening endometrial biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85712, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Compass Clinical Research
San Ramon, California, 94583, United States
Altus Research
Lake Worth, Florida, 33461, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Medical Associates
Dubuque, Iowa, 52002, United States
Physicians for Women
Cary, North Carolina, 27511, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
HWC Women's Research Center
Miamisburg, Ohio, 45342, United States
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201, United States
Gaffney Pharmaceutical Research
Gaffney, South Carolina, 29340, United States
Greenville Pharma Research
Greenville, South Carolina, 29615, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 complete study data.
Results Point of Contact
- Title
- Jennifer L. Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- STUDY DIRECTOR
Andre vanAs, MD, PhD
Repros Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2007
First Posted
November 9, 2007
Study Start
November 1, 2007
Primary Completion
May 1, 2009
Study Completion
July 1, 2009
Last Updated
August 25, 2014
Results First Posted
August 25, 2014
Record last verified: 2014-08