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
This study has been completed.
Sponsor:
Repros Therapeutics Inc.
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
First received: August 11, 2009
Last updated: December 9, 2010
Last verified: December 2010
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Purpose
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).
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Menopause
Drug Information available for:
Progesterone
U.S. FDA Resources
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:
|
|
Experimental: Proellex 12.5 mg
Proellex® 12.5 mg capsules once a day
|
Drug: Proellex®
12.5 mg daily
Other Names:
|
|
Placebo Comparator: Placebo
capsule once a day
|
Drug: Placebo |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958334
Locations
| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015 | |
| Arizona Wellness Centre for Women | |
| Phoenix, Arizona, United States, 85032 | |
| 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 | |
| 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: | Andre vanAs, MD, PhD, Repros Therapeutics |
| 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: | December 9, 2010 |
| 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 Progesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013