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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00882258
First received: April 14, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: 12.5 mg Proellex
Drug: 25 mg Proellex
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12.5 mg Proellex
Proellex 12.5 mg daily
Drug: 12.5 mg Proellex
12.5 mg Proellex administered orally daily
Other Names:
  • CDB-4124
  • Telapristone acetate
Experimental: 25 mg Proellex daily
Proellex 25 mg
Drug: 25 mg Proellex
25 mg Proellex administered orally daily
Other Names:
  • CDB-4124
  • Telapristone acetate
Placebo Comparator: Placebo
Placebo daily
Drug: Placebo
Administered orally daily
Other Name: Dummy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00882258

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

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00882258     History of Changes
Other Study ID Numbers: ZPU-003
Study First Received: April 14, 2009
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 28, 2014