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Vaginal Infections |
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Clinical Trial: Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
This study is currently recruiting patients.
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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 IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Diagnostic, 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
Secondary Outcomes: -Frequency of delivery preterm; -Response to tocolytic therapy; -Number of infant hospital days from delivery to discharge
Expected Total Enrollment: 636
Study start: April 2004
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 "premie")
- Patients must be 18-45 years of age
Eligibility
Ages Eligible for Study: 18 Years - 45 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Single-baby pregnancy
- Previous preterm birth
Exclusion Criteria:
- Twins and triplets
Location and Contact Information
Alabama
University of South Alabama Department of OBGYN, Mobile, Alabama, 36604, United States; Recruiting
251-415-1490
Kathy Porter, MD, Principal Investigator
Georgia
Northside Maternal Fetal Specialists, Atlanta, Georgia, 30342, United States; Recruiting
Daniel P Eller, MD, Principal Investigator
Kentucky
Universtiy of Kentucky, Medical Center, Lexington, Kentucky, 40536, United States; Recruiting
859-257-2321
Emily DeFranco, DO, Principal Investigator
Central Baptist Hospital, Lexington, Kentucky, 40503, United States; Recruiting
859-260-6970
John O'Brien, MD, Principal Investigator
Maternal Fetal Medicine Norton Suburban Hospital, Louisville, Kentucky, 40207, United States; Recruiting
1-866-882-5750
Jonathan Weeks, MD, Principal Investigator
Louisiana
Louisiana State University Health Sciences Center-Shreveport, Shreveport, Louisiana, 71103, United States; Recruiting
318-675-5349
David F Lewis, MD, Principal Investigator
Maternal Fetal Medicine Center, Woman's Hospital, Baton Rouge, Louisiana, 70815, United States; Recruiting
Alfred G Robichaux, MD, Principal Investigator
New Jersey
Department of OBGYN, St. Barnabas Medical Center, Livingston, New Jersey, 07039, United States; Recruiting
973-322-5287
Leon Smith, MD, Principal Investigator
North Carolina
Pitt County Memorial Hospital, Greenville, North Carolina, 27834, United States; Recruiting
252-744-5695
Edward Newton, MD, Principal Investigator
Ohio
University of Cincinnati, Cincinnati, Ohio, 45219, United States; Recruiting
513-558-8464
Helen How, MD, Principal Investigator
MacDonald Clinical Trials Unit, University Hospitals of Cleveland, Cleveland, Ohio, 44104-5034, United States; Recruiting
216-844-8677
George van Buren, MD, Principal Investigator
South Carolina
Center for Women's Medicine, Greenville, South Carolina, 29605, United States; Recruiting
864-455-6066
Kenneth F Trofatter, MD, PhD, Principal Investigator
Tennessee
Regional Obstetrical Consultants, Chattanooga, Tennessee, 37403, United States; Recruiting
423-553-9909
David Adair, MD, Principal Investigator
Texas
Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States; Recruiting
806-743-2354
Arthur T Evans, MD, Principal Investigator
Virginia
EVMS Maternal-Fetal Medicine, Hofheimer Hall, Norfolk, Virginia, 23507, United States; Recruiting
Bonnie Dattel, MD, Principal Investigator
George W Creasy, MD, Study Director, VP Clinical Research; Columbia Laboratories, Inc
More Information
Click here for more information about the PROTERM study: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Prochieve 8% Progesterone Gel in Preventing Preterm Delivery
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.
Record last reviewed: March 2005
Last Updated: March 11, 2005
Record first received: June 25, 2004
ClinicalTrials.gov Identifier: NCT00086177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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