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

NCT ID: NCT00556075

Last Updated: 2014-08-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule daily for 4 months

25 mg

Proellex 25 mg once daily

Group Type EXPERIMENTAL

Proellex 25 mg

Intervention Type DRUG

1 capsule daily for 4 months

50 mg

Proellex 50 mg once daily

Group Type EXPERIMENTAL

Proellex 50 mg

Intervention Type DRUG

2 capsules daily for 4 months

Interventions

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Proellex 25 mg

1 capsule daily for 4 months

Intervention Type DRUG

Placebo

1 capsule daily for 4 months

Intervention Type DRUG

Proellex 50 mg

2 capsules daily for 4 months

Intervention Type DRUG

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Repros Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre vanAs, MD, PhD

Role: STUDY_DIRECTOR

Repros Therapeutics Inc.

Locations

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Advanced Clinical Therapeutics, LLC

Tucson, Arizona, United States

Site Status

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Site Status

Medical Center for Clinical Research

San Diego, California, United States

Site Status

Compass Clinical Research

San Ramon, California, United States

Site Status

Altus Research

Lake Worth, Florida, United States

Site Status

Comprehensive Clinical Trials

West Palm Beach, Florida, United States

Site Status

Medical Associates

Dubuque, Iowa, United States

Site Status

Physicians for Women

Cary, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Site Status

HWC Women's Research Center

Miamisburg, Ohio, United States

Site Status

SC Clinical Research Center, LLC

Columbia, South Carolina, United States

Site Status

Gaffney Pharmaceutical Research

Gaffney, South Carolina, United States

Site Status

Greenville Pharma Research

Greenville, South Carolina, United States

Site Status

Advanced Research Associates

Corpus Christi, Texas, United States

Site Status

Clinical Trials of Texas/Institute for Women's Health

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas/Seven Oaks Women's Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ZPE-201

Identifier Type: -

Identifier Source: org_study_id

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