A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery

Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2015

At a glance

  • Drugs Progesterone (Primary)
  • Indications Pregnancy; Preterm birth
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 26 Apr 2011 Results from this study, were used in part to support an NDA submission seeking approval of Prochieve in women with short cervical length.
    • 18 Aug 2010 Actual end date (Mar 2009) added as reported by ClinicalTrials.gov.
    • 18 Aug 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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