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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


Phase 2
18 Years
50 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

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 ResearchPhoenix, Arizona  85015
Downtown Women's Health CareDenver, Colorado  80218
Insignia Clinical Research (Tampa Bay Women's Center)Tampa, Florida  33607
SC Clinical Research CenterColumbia, South Carolina  29201
Advances in Health Inc.Houston, Texas  77030
Arizona Wellness Centre for WomenPhoenix, Arizona  85032
Women's Health Care, Inc.San Diego, California  92123
Medical Centre for Clinical ResearchSan Diego, California  92108
Affiliated Clinical Research, Inc.Las Vegas, Nevada  89128
Obstetrical & Gynecolgical Associates, PA (OGA)Houston, Texas  77054
Women's Clinical Research CentreSeattle, Washington  98105