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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History