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Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
First received: August 11, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

ZPU-003 EXT is a 2-year extension study of ZPU-003 to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.


Condition Intervention Phase
Uterine Fibroids
Drug: Proellex®
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. [ Time Frame: baseline, 14 months (3-4 cycles), 17 months ] [ Designated as safety issue: No ]
    An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.


Secondary Outcome Measures:
  • Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only) [ Time Frame: baseline and 14 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proellex 25 mg
Proellex® 12.5 mg capsules twice a day
Drug: Proellex®
25 mg daily (two 12.5 mg capsules)
Other Names:
  • CDB-4124
  • telapristone acetate
Experimental: Proellex 12.5 mg
Proellex® 12.5 mg capsules once a day
Drug: Proellex®
12.5 mg daily
Other Names:
  • CDB-4124
  • telapristone acetate
Placebo Comparator: Placebo
capsule once a day
Drug: Placebo
Treatment with no active ingredients
Other Names:
  • Dummy
  • Sham treatment

Detailed Description:

ZPU-003 EXT is a 2-year extension study of ZPU-003. The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

  Eligibility

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

Inclusion Criteria:

  • Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

Exclusion Criteria:

  • Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
  • Pregnant or breastfeeding.
  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: NCT00958334

Locations
United States, Arizona
Arizona Wellness Centre for Women
Phoenix, Arizona, United States, 85032
Women's Health Research
Phoenix, Arizona, United States, 85015
United States, California
Medical Centre for Clinical Research
San Diego, California, United States, 92108
Women's Health Care, Inc.
San Diego, California, United States, 92123
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80218
United States, Florida
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, United States, 33607
United States, Nevada
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 van As, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00958334     History of Changes
Other Study ID Numbers: ZPU-003 Ext
Study First Received: August 11, 2009
Results First Received: August 26, 2010
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids

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

ClinicalTrials.gov processed this record on November 27, 2014