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Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

This study is currently recruiting participants.
Verified by Repros Therapeutics Inc., May 2008

Sponsored by: Repros Therapeutics Inc.
Information provided by: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00556075
  Purpose

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.


Condition Intervention Phase
Endometriosis
Drug: Proellex 25 mg
Drug: Placebo
Drug: Proellex 50 mg
Phase II

MedlinePlus related topics:   Endometriosis   

ChemIDplus related topics:   Progesterone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Difference between the 50 mg Proellex group and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Difference between the 25 mg and 50 mg Proellex groups and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between each treatment group in the subject diary composite pain score at the monthly visits [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Time to pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ] [ Designated as safety issue: No ]
  • Duration of pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ] [ Designated as safety issue: No ]
  • The number of days with pain as determined by data recorded in the subject diaries, analyzed between treatment groups at the monthly visits [ Time Frame: days ] [ Designated as safety issue: No ]

Estimated Enrollment:   75
Study Start Date:   November 2007
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
C: Placebo Comparator
Placebo
Drug: Placebo
1 capsule daily for 4 months
A: Experimental
Proellex 25 mg
Drug: Proellex 25 mg
1 capsule daily for 4 months
B: Experimental
Proellex 50 mg
Drug: Proellex 50 mg
2 capsules daily for 4 months

  Eligibility
Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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)
  • Other inclusion criteria may apply

Exclusion Criteria:

  • 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
  • Other exclusion criteria may apply
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556075

Contacts
Contact: John Weiler, MD     319-626-8888     jweiler@compleware.com    
Contact: Michelle Moore     319-626-8888     mmoore@compleware.com    

Locations
United States, Arizona
Advanced Clinical Therapeutics, LLC     Recruiting
      Tucson, Arizona, United States, 85712
      Contact: Joanie Seibold     520-323-9601     jseibold@advancedtherapies.com    
      Principal Investigator: Walter Patton, MD            
United States, Arkansas
Lynn Institute of the Ozarks     Recruiting
      Little Rock, Arkansas, United States, 72205
      Contact: Holly Jarrell     501-975-2000     hjarrell@lhsi.net    
      Principal Investigator: Caroline May, MD            
United States, California
Compass Clinical Research     Recruiting
      San Ramon, California, United States, 94583
      Contact: Jennifer McWatters     925-973-5012     jennifer.mcwatters@integramed.com    
      Principal Investigator: Donald Galen, MD            
Medical Center for Clinical Research     Recruiting
      San Diego, California, United States, 92108
      Contact: Karen Wilborn-Mylerberg     619-521-2830     kwilborn@redwire.net    
      Principal Investigator: William Koltun, MD            
United States, Florida
Comprehensive Clinical Trials     Recruiting
      West Palm Beach, Florida, United States, 33409
      Contact: Virginia Piechocniski     561-478-3177     regulatory@cctllc.net    
      Principal Investigator: Ronald Ackerman, MD            
Altus Research     Recruiting
      Lake Worth, Florida, United States, 33461
      Contact: Cynthia Abath     561-296-7397     cindyabath@aol.com    
      Principal Investigator: Samuel Lederman, MD            
United States, Iowa
Medical Associates     Recruiting
      Dubuque, Iowa, United States, 52002
      Contact: Maureen Runde     563-584-4139     mmrunde@mahealthcare.com    
      Principal Investigator: Trupti Mehta, MD            
United States, North Carolina
Wake Research Associates     Recruiting
      Raleigh, North Carolina, United States, 27612
      Contact: Marsha Peery     919-781-2514     mpeery@wakeresearch.com    
      Principal Investigator: Pouru Bhiwandiwalla, MD            
Physicians for Women     Recruiting
      Cary, North Carolina, United States, 27511
      Contact: Marcia Ramirez     919-678-6907     marciar@physicians-for-women.com    
      Principal Investigator: Geoff Seidel, MD            
United States, Ohio
HWC Women's Research Center     Recruiting
      Miamisburg, Ohio, United States, 45342
      Contact: Angela Shields     937-866-1187     ashields@hwcwrc.com    
      Principal Investigator: James Huey, MD            
Rapid Medical Research, Inc.     Recruiting
      Cleveland, Ohio, United States, 44122
      Contact: Clauida Lanesa     216-539-8384     claudia@rapidmedicalresearch.com    
      Principal Investigator: Mira Baron, MD            
United States, South Carolina
SC Clinical Research Center, LLC     Recruiting
      Columbia, South Carolina, United States, 29201
      Contact: Margaret Holt     803-988-1438     pholt@scclinicalresearch.com    
      Principal Investigator: Myles Davis, MD            
Greenville Pharma Research     Recruiting
      Greenville, South Carolina, United States, 29615
      Contact: Steve Clemons     864-770-0892     sclemons@greenvilleMedResearch.com    
      Principal Investigator: David Godwin, MD            
Gaffney Pharmaceutical Research     Recruiting
      Gaffney, South Carolina, United States, 29340
      Contact: Tammy Tate     864-488-1283     ttategpr@bellsouth.net    
      Principal Investigator: Steven Lewis, MD            
United States, Texas
Advanced Research Associates     Recruiting
      Corpus Christi, Texas, United States, 78414
      Contact: Bonnie Gutierrez     361-906-1277 ext 104     bonnie@araresearch.com    
      Principal Investigator: Charles Eubank, MD            
Clinical Trials of Texas/Seven Oaks Women's Center     Recruiting
      San Antonio, Texas, United States, 78229
      Contact: Mary Jo Perez-Jenkins     210-949-0122     mjenkins@cttexas.com    
      Principal Investigator: Brian Harle, MD            
Clinical Trials of Texas/Institute for Women's Health     Recruiting
      San Antonio, Texas, United States, 78229
      Contact: Kate Blair     210-949-0122     kblair@cttexas.com    
      Principal Investigator: Jose Ruiz, MD            

Sponsors and Collaborators
Repros Therapeutics Inc.

Investigators
Study Director:     Andre vanAs, MD, PhD     Repros Therapeutics Inc.    
  More Information

Responsible Party:   Andre vanAs, MD, PhD ( Repros Therapeutics Inc. )
Study ID Numbers:   ZPE-201
First Received:   November 7, 2007
Last Updated:   May 27, 2008
ClinicalTrials.gov Identifier:   NCT00556075
Health Authority:   United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Endometriosis  
Pelvic pain  
Oral progesterone blocker  

Study placed in the following topic categories:
Genital Diseases, Female
Pelvic Pain
Progesterone
Endometriosis
Pain

ClinicalTrials.gov processed this record on September 05, 2008




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