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

This study has been terminated.
(Clinical hold for safety)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00556075
First received: November 7, 2007
Last updated: June 23, 2014
Last verified: June 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 67
Study Start Date: November 2007
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: C
Placebo
Drug: Placebo
1 capsule daily for 4 months
Experimental: A
Proellex 25 mg
Drug: Proellex 25 mg
1 capsule daily for 4 months
Experimental: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States, 85712
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
Compass Clinical Research
San Ramon, California, United States, 94583
United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
Comprehensive Clinical Trials
West Palm Beach, Florida, United States, 33409
United States, Iowa
Medical Associates
Dubuque, Iowa, United States, 52002
United States, North Carolina
Physicians for Women
Cary, North Carolina, United States, 27511
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
HWC Women's Research Center
Miamisburg, Ohio, United States, 45342
United States, South Carolina
SC Clinical Research Center, LLC
Columbia, South Carolina, United States, 29201
Gaffney Pharmaceutical Research
Gaffney, South Carolina, United States, 29340
Greenville Pharma Research
Greenville, South Carolina, United States, 29615
United States, Texas
Advanced Research Associates
Corpus Christi, Texas, United States, 78414
Clinical Trials of Texas/Seven Oaks Women's Center
San Antonio, Texas, United States, 78229
Clinical Trials of Texas/Institute for Women's Health
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00556075     History of Changes
Other Study ID Numbers: ZPE-201
Study First Received: November 7, 2007
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 20, 2014