Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

July 3, 2014 updated by: Repros Therapeutics Inc.

A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Arizona Wellness Centre for Women
      • Tuscon, Arizona, United States, 85712
        • Visions Clinical Research Tuscon
    • California
      • San Diego, California, United States, 92123
        • Women's Health Care, Inc.
      • San Diego, California, United States, 92108
        • Medical Centre for Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80218
        • Downtown Women's Health Care
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • Miami, Florida, United States, 33143
        • Miami Research Associates, Women's Health Studies
      • Tampa, Florida, United States, 33607
        • Insignia Clinical Research (Tampa Bay Women's Center)
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Affiliated Clinical Research, Inc.
      • Las Vegas, Nevada, United States, 89106
        • Caring for Women
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SC Clinical Research Center
    • Texas
      • Houston, Texas, United States, 77030
        • Advances in Health Inc.
      • Houston, Texas, United States, 77054
        • Obstetrical & Gynecolgical Associates, PA (OGA)
    • Washington
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
  • Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion Criteria:

  • Post-menopausal women, as defined as one or more of the following:

    1. six months or more (immediately prior to Screening visit) without a menstrual period, or
    2. prior hysterectomy and/or oophorectomy
  • Subjects with documented endometriosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo daily
Drug: Placebo
Administered orally daily
Other Names:
  • Dummy
Experimental: 12.5 mg Proellex
Proellex 12.5 mg daily
Drug: 12.5 mg Proellex
12.5 mg Proellex administered orally daily
Other Names:
  • Telapristone acetate
  • CDB-4124
Experimental: 25 mg Proellex daily
Proellex 25 mg
Drug: 25 mg Proellex
25 mg Proellex administered orally daily
Other Names:
  • Telapristone acetate
  • CDB-4124

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
Time Frame: 91 days
91 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
Time Frame: 91 days
91 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Investigators

  • Study Director: Andre VanAs, PhD, MD, Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPU-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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