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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.

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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.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jan 2020

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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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