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Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

NCT00086177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2010-08-19

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

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

Sponsors & Collaborators

  • Juniper Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • George W Creasy, MD · VP Clinical Research; Columbia Laboratories, Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-01-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00086177 on ClinicalTrials.gov