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Center, Open-Label, Three Cycle Extension Study Evaluating Safety and Efficacy of a 25 mg Daily Dose of Proellex® (CDB-4124) In Pre-Menopausal Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext


Phase 2
18 Years
50 Years
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

Center, Open-Label, Three Cycle Extension Study Evaluating Safety and Efficacy of a 25 mg Daily Dose of Proellex® (CDB-4124) In Pre-Menopausal Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext


Inclusion Criteria:



- Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria:

- All other subjects

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To further evaluate adverse events of a 25 mg dose of Proellex® administered to women once daily for three 4 month cycles separated by off-drug intervals.

Outcome Time Frame:

three 4 month cycles separated by off-drug intervals

Safety Issue:

Yes

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 Extension 2

NCT ID:

NCT00958893

Start Date:

June 2008

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Advances in Health, Inc.Houston, Texas  77030