Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

Pregnancy Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

• NCT number: NCT00086177
• Study type: Interventional
• Source: Juniper Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: April 2004
• Completion date: March 2009