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Sponsored by: |
Columbia Laboratories |
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Information provided by: | Columbia Laboratories |
ClinicalTrials.gov Identifier: | NCT00086177 |
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.
Condition | Intervention | Phase |
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Pregnancy |
Drug: 8% progesterone vaginal gel Drug: Placebo Vaginal Gel |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 636 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Progesterone 8% vaginal gel
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Drug: 8% progesterone vaginal gel
Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
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2: Placebo Comparator
Placebo Vaginal Gel
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Drug: Placebo Vaginal Gel
Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
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Patients who participate are to have:
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | George W Creasy, MD | VP Clinical Research; Columbia Laboratories, Inc |
Responsible Party: | VP Clinical Research, Columbia Laboratories ( George W. Creasy, MD, FACOG ) |
Study ID Numbers: | COL-1620-300 |
Study First Received: | June 25, 2004 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00086177 |
Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India; Czech Republic: Ethics Committee; Chile: Instituto de Salud Publica de Chile; South Africa: National Health Research Ethics Council |
Pregnancy, prevention of preterm birth, prevention of preterm labor, |
Pregnancy Complications Progesterone Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |
Progestins Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |