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A Phase III, Open-Label, Parallel, Randomized, Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304


Phase 3
18 Years
N/A
Not Enrolling
Female
Uterine Fibroids

Thank you

Trial Information

A Phase III, Open-Label, Parallel, Randomized, Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304


Inclusion Criteria:



- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal
Ultrasound (TVU)

- Subject has a menstrual cycle lasting from 20 to 40 days.

- Subject must have satisfactorily completed all study visits from the previous study
in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301,
ZPU-302, ZPU-303, or ZPU-304.

- Subjects who met treatment stopping rules as per the DILI Guidance requirements while
participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the incidence of adverse events (AE) and serious adverse events (SAEs)

Outcome Time Frame:

During two 4 month treatment periods

Safety Issue:

Yes

Principal Investigator

Andre vanAS, PhD, Md

Investigator Role:

Study Director

Investigator Affiliation:

Repros Therapeutics Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ZPU-307

NCT ID:

NCT01069120

Start Date:

April 2009

Completion Date:

August 2009

Related Keywords:

  • Uterine Fibroids
  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

Visions Clinical ResearchBoynton Beach, Florida  33472
Insignia Clinical Research (Tampa Bay Women's Center)Tampa, Florida  33607
The Women's Hospital of Texas, Clinical Research CenterHouston, Texas  77054
Advances in Health IncHouston, Texas  77030