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

Primary Purpose

Endometriosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proellex 25 mg
Placebo
Proellex 50 mg
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Pelvic pain, Oral progesterone blocker

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Therapeutics, LLC
  • Lynn Institute of the Ozarks
  • Medical Center for Clinical Research
  • Compass Clinical Research
  • Altus Research
  • Comprehensive Clinical Trials
  • Medical Associates
  • Physicians for Women
  • Wake Research Associates
  • Rapid Medical Research, Inc.
  • HWC Women's Research Center
  • SC Clinical Research Center, LLC
  • Gaffney Pharmaceutical Research
  • Greenville Pharma Research
  • Advanced Research Associates
  • Clinical Trials of Texas/Institute for Women's Health
  • Clinical Trials of Texas/Seven Oaks Women's Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

25 mg

50 mg

Arm Description

Placebo once daily

Proellex 25 mg once daily

Proellex 50 mg once daily

Outcomes

Primary Outcome Measures

Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score

Secondary Outcome Measures

Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits

Full Information

First Posted
November 7, 2007
Last Updated
August 8, 2014
Sponsor
Repros Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00556075
Brief Title
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Clinical hold for safety
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Pelvic pain, Oral progesterone blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Arm Title
25 mg
Arm Type
Experimental
Arm Description
Proellex 25 mg once daily
Arm Title
50 mg
Arm Type
Experimental
Arm Description
Proellex 50 mg once daily
Intervention Type
Drug
Intervention Name(s)
Proellex 25 mg
Intervention Description
1 capsule daily for 4 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily for 4 months
Intervention Type
Drug
Intervention Name(s)
Proellex 50 mg
Intervention Description
2 capsules daily for 4 months
Primary Outcome Measure Information:
Title
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time Frame
4 months
Title
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
Secondary Outcome Measure Information:
Title
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Time Frame
monthly
Title
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time Frame
days
Title
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time Frame
days
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre vanAs, MD, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Compass Clinical Research
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Comprehensive Clinical Trials
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Medical Associates
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52002
Country
United States
Facility Name
Physicians for Women
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
HWC Women's Research Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
SC Clinical Research Center, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Gaffney Pharmaceutical Research
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Greenville Pharma Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Clinical Trials of Texas/Institute for Women's Health
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trials of Texas/Seven Oaks Women's Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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