NCT00086177

Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: Juniper Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.

Detailed description

Patients who participate are to have: * A single baby pregnancy (no twins or triplets allowed) * Patients will start treatment before pregnancy week 23 * Patients must have a previous preterm birth (a "preemie") * Patients must be 18-45 years of age

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	8% progesterone vaginal gel	Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
DRUG	Placebo Vaginal Gel	Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-01-01
• Completion: 2009-03-01
• First posted: 2004-06-29
• Last updated: 2010-08-19

Locations

45 sites across 1 country: United States