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
18 Years
50 Years
Female
Uterine Fibroids
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Description:
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.
Outcome Time Frame:
baseline, 14 months (3-4 cycles), 17 months
Safety Issue:
No
Principal Investigator
Andre van As, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Repros Therapeutics Inc.
Authority:
United States: Food and Drug Administration
Study ID:
ZPU-003 Ext
NCT ID:
NCT00958334
Start Date:
September 2006
Completion Date:
October 2008
Related Keywords:
- Uterine Fibroids
- Uterine fibroids
- Leiomyoma
- Myofibroma
Name | Location |
|---|---|
| Women's Health Research | Phoenix, Arizona 85015 |
| Downtown Women's Health Care | Denver, Colorado 80218 |
| Insignia Clinical Research (Tampa Bay Women's Center) | Tampa, Florida 33607 |
| SC Clinical Research Center | Columbia, South Carolina 29201 |
| Advances in Health Inc. | Houston, Texas 77030 |
| Arizona Wellness Centre for Women | Phoenix, Arizona 85032 |
| Women's Health Care, Inc. | San Diego, California 92123 |
| Medical Centre for Clinical Research | San Diego, California 92108 |
| Affiliated Clinical Research, Inc. | Las Vegas, Nevada 89128 |
| Obstetrical & Gynecolgical Associates, PA (OGA) | Houston, Texas 77054 |
| Women's Clinical Research Centre | Seattle, Washington 98105 |
