ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

This study is currently recruiting patients.

Sponsored by: Columbia Laboratories
Information provided by: Columbia Laboratories

Purpose

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 Treatment or Intervention Phase
Pregnancy
  Drug: 8% progesterone vaginal gel
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, 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

Further Study Details: 

Expected Total Enrollment:  636

Study start: April 2004

Patients who participate are to have:

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


Alabama
      University of South Alabama Department of OBGYN, Mobile,  Alabama,  36604,  United States; Recruiting
Jenny Chastang, RN  251-415-1598    jchastang@usouthal.edu 
Kathy Porter, MD,  Principal Investigator

Kentucky
      Universtiy of Kentucky, Medical Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Ken Muse, MD  859-323-5410    muse@uky.edu 
Emily DeFranco, DO,  Principal Investigator

      Central Baptist Hospital, Lexington,  Kentucky,  40503,  United States; Recruiting
Lori Poynter, RN, BSN  859-260-6295    lpoynter@bhsi.com 
John O'Brien, MD,  Principal Investigator

      Maternal Fetal Medicine Norton Suburban Hospital, Louisville,  Kentucky,  40207,  United States; Recruiting
Joan Bramlett, WHNP-c, MSN  502-767-0984    joan.bramlett@nortonhealthcare.org 
Jonathan Weeks, MD,  Principal Investigator

Louisiana
      Louisiana State University Health Sciences Center-Shreveport, Shreveport,  Louisiana,  71103,  United States; Recruiting
Lisa Philibert, RN  318-675-5692    lphili@lsuhsc.edu 
David F Lewis, MD,  Principal Investigator

      Maternal Fetal Medicine Center, Woman's Hospital, Baton Rouge,  Louisiana,  70815,  United States; Recruiting
Traci W Torres  225-924-8338    Bsc-twt@womans.com 
Alfred G Robichaux, MD,  Principal Investigator

North Carolina
      Center for Women's Medicine, Greenville,  North Carolina,  29605,  United States; Recruiting
Karen R Nichols  864-455-5932    knichols@ghs.org 
Kenneth F Trofatter, MD, PhD,  Principal Investigator

      Pitt County Memorial Hospital, Greenville,  North Carolina,  27834,  United States; Recruiting
Olga Thorne  252-916-8062    thorneo@mail.ecu.edu 
Edward Newton, MD,  Principal Investigator

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45219,  United States; Recruiting
Katherine Recht, Res Asst II  513-584-2373    rechtkr@ucmail.uc.edu 
Helen How, MD,  Principal Investigator

      MacDonald Clinical Trials Unit, University Hospitals of Cleveland, Cleveland,  Ohio,  44104-5034,  United States; Recruiting
Carolyn B Moes, CNM, MSN  216-844-5186    carolyn.moes@uhhs.com 
George van Buren, MD,  Principal Investigator

Tennessee
      Regional Obstetrical Consultants, Chattanooga,  Tennessee,  37403,  United States; Recruiting
Lorrie Mason, MSN  423-664-4460    lorrie@rocob.com 
David Adair, MD,  Principal Investigator

Texas
      Texas Tech University Health Sciences Center, Lubbock,  Texas,  79430,  United States; Recruiting
Cathy Hudson, CCRC  806-743-4492    catherine.hudson@ttuhsc.edu 
Arthur T Evans, MD,  Principal Investigator

More Information

Publications

da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24.

Study ID Numbers:  COL-1620-300
Record last reviewed:  August 2004
Record first received:  June 25, 2004
ClinicalTrials.gov Identifier:  NCT00086177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act