Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Last updated: August 5, 2014
Sponsor: Repros Therapeutics Inc.
Overall Status: Terminated

Phase

3

Condition

Uterine Fibroids

Uterina Myoma

Desmoid Tumors

Treatment

N/A

Clinical Study ID

NCT01069120
ZPU-307
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

Safety and efficacy study of 25 and 50 mg doses of Proellex

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 1 uterine fibroid must be identifiable and measurable by TransvaginalUltrasound (TVU)

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

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

Exclusion

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 whileparticipating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Study Design

Total Participants: 27
Study Start date:
April 01, 2009
Estimated Completion Date:
August 31, 2009

Study Description

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Connect with a study center

  • Visions Clinical Research

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Insignia Clinical Research (Tampa Bay Women's Center)

    Tampa, Florida 33067
    United States

    Site Not Available

  • Advances in Health Inc

    Houston, Texas 77030
    United States

    Site Not Available

  • The Women's Hospital of Texas, Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

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