Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
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
1 other identifier
interventional
636
1 country
45
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pregnancy
Started Apr 2004
Longer than P75 for phase_3 pregnancy
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 25, 2004
CompletedFirst Posted
Study publicly available on registry
June 29, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 19, 2010
August 1, 2010
2.8 years
June 25, 2004
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of delivery <=32 weeks
18 weeks gestation through delivery
Secondary Outcomes (3)
Frequency of delivery preterm
18 weeks gestation through delivery
Response to tocolytic therapy
Onset of preterm labor through resolution or delivery
Number of infant hospital days from delivery to discharge
Delivery date through hospital discharge date of infant
Study Arms (2)
1
ACTIVE COMPARATORProgesterone 8% vaginal gel
2
PLACEBO COMPARATORPlacebo Vaginal Gel
Interventions
Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Eligibility Criteria
You may not qualify if:
- The female subject is between 18 and 45 years of age at the time of screening.
- The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks.
- The subject speaks either English or a common local language.
- The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained, and all her questions are answered to her satisfaction and understanding.
- In the opinion of the investigator, the subject is able to understand the study and is able to give informed consent, as well as participate in it and adhere to study procedures.
- The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel.
- The subject has been treated with a progestogen within the previous 4 weeks.
- The subject is currently being treated for a seizure disorder, has an unstable psychiatric disorder, is taking antihypertensive therapy for chronic hypertension at the time of enrollment, has a history of congestive heart failure or chronic renal failure, or has uncontrolled diabetes mellitus (known end-organ dysfunction secondary to vascular disease).
- The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders.
- The subject has liver dysfunction or disease.
- The subject has known or suspected malignancy of the breast or genital organs.
- The subject is currently participating in another investigational study or has participated in an investigational drug study within one month prior to screening for this study.
- The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality.
- The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus)
- The subject has a multifetal gestation.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
University of South Alabama Department of OBGYN
Mobile, Alabama, 36604, United States
Visions Clinical Research-Tucson
Tucson, Arizona, 85712, United States
Women's Health Department
Colton, California, 92324, United States
SanDiego Perinatal Center
San Diego, California, 92123, United States
Harbor - UCLA Medical Center
Torrance, California, 90509, United States
Kaiser Permanente
Denver, Colorado, 80205, United States
Northside Maternal Fetal Specialists
Atlanta, Georgia, 30342, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Maternal Fetal Medicine Norton Suburban Hospital
Louisville, Kentucky, 40207, United States
Maternal Fetal Medicine &Woman's Health Research
Baton Rouge, Louisiana, 70815, United States
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins Community Physicians
Baltimore, Maryland, 21211, United States
Holy Cross Hospital
Silver Springs, Maryland, 20910, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center -MFM
Brighton, Massachusetts, 02135, United States
St. Louis University
St Louis, Missouri, 63021, United States
Washington University
St Louis, Missouri, 63110, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Department of OBGYN, St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
St. Luke's - Roosevelt Hospital
New York, New York, 10019, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27834, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103, United States
Ohio Permanente Medical Group
Bedford, Ohio, 44146, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
MacDonald Clinical Trials Unit, University Hospitals of Cleveland
Cleveland, Ohio, 44104-5034, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Temple University Medical Center
Philadelphia, Pennsylvania, 19140, United States
Abington Primary Women's Healthcare
Willow Grove, Pennsylvania, 19090, United States
University Medical Group, Dept of OB/GYN
Greenville, South Carolina, 29605, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403, United States
Gynecology & Obstetrics
Memphis, Tennessee, 38120, United States
Womens Partner In Health
Austin, Texas, 78705, United States
Health Central Women's Care
Dallas, Texas, 75231, United States
Clinical Research Center of Houston
Houston, Texas, 77054, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Texas Tech Health Sciences Center - Odessa
Odessa, Texas, 79763, United States
EVMS Maternal-Fetal Medicine, Hofheimer Hall
Norfolk, Virginia, 23507, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (4)
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. doi: 10.1067/mob.2003.41.
PMID: 12592250BACKGROUNDO'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):687-96. doi: 10.1002/uog.5158.
PMID: 17899572RESULTDeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.
PMID: 17899571RESULTO'Brien JM, Defranco EA, Adair CD, Lewis DF, Hall DR, How H, Bsharat M, Creasy GW; Progesterone Vaginal Gel Study Group. Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2009 Dec;34(6):653-9. doi: 10.1002/uog.7338.
PMID: 19918965DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
George W Creasy, MD
VP Clinical Research; Columbia Laboratories, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2004
First Posted
June 29, 2004
Study Start
April 1, 2004
Primary Completion
January 1, 2007
Study Completion
March 1, 2009
Last Updated
August 19, 2010
Record last verified: 2010-08