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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00556075
Other study ID # ZPE-201
Secondary ID
Status Terminated
Phase Phase 2
First received November 7, 2007
Last updated August 8, 2014
Start date November 2007
Est. completion date July 2009

Study information

Verified date August 2014
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 67
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Proellex 25 mg
1 capsule daily for 4 months
Placebo
1 capsule daily for 4 months
Proellex 50 mg
2 capsules daily for 4 months

Locations

Country Name City State
United States Physicians for Women Cary North Carolina
United States Rapid Medical Research, Inc. Cleveland Ohio
United States SC Clinical Research Center, LLC Columbia South Carolina
United States Advanced Research Associates Corpus Christi Texas
United States Medical Associates Dubuque Iowa
United States Gaffney Pharmaceutical Research Gaffney South Carolina
United States Greenville Pharma Research Greenville South Carolina
United States Altus Research Lake Worth Florida
United States Lynn Institute of the Ozarks Little Rock Arkansas
United States HWC Women's Research Center Miamisburg Ohio
United States Wake Research Associates Raleigh North Carolina
United States Clinical Trials of Texas/Institute for Women's Health San Antonio Texas
United States Clinical Trials of Texas/Seven Oaks Women's Center San Antonio Texas
United States Medical Center for Clinical Research San Diego California
United States Compass Clinical Research San Ramon California
United States Advanced Clinical Therapeutics, LLC Tucson Arizona
United States Comprehensive Clinical Trials West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score 4 months No
Primary Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score 4 months No
Secondary Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits monthly No
Secondary Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries days No
Secondary Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries days No
Secondary The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits days No
See also
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Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
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Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4