A Phase 2, Three-arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound.

Trial Profile

A Phase 2, Three-arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound.

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Oct 2014

At a glance

  • Drugs Telapristone (Primary)
  • Indications Uterine leiomyoma
  • Focus Therapeutic Use
  • Sponsors Repros Therapeutics
  • Most Recent Events

    • 03 Jan 2013 To date, 15 of 40 patients completing the primary trial have elected to enroll in the extension study according to a Repros Therapeutics media release.
    • 03 Jan 2013 Top-line results have been reported for the primary study in a Repros Therapeutics media release.
    • 20 Dec 2012 Integrated ClincialTrials.gov record of extension study (NCT01739621).
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