An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

Last updated: August 8, 2014
Sponsor: Repros Therapeutics Inc.
Overall Status: Terminated

Phase

2

Condition

Sarcoma (Pediatric)

Uterina Myoma

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT00958893
ZPU-003 Extension 2
  • Ages 18-50
  • Female

Study Summary

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • All other subjects

Study Design

Total Participants: 4
Study Start date:
June 01, 2008
Estimated Completion Date:
August 31, 2009

Study Description

This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Connect with a study center

  • Advances in Health, Inc.

    Houston,, Texas 77030
    United States

    Site Not Available

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