Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

PHASE3CompletedINTERVENTIONAL
Enrollment

636

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

January 31, 2007

Study Completion Date

March 31, 2009

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

Trial Locations (45)

10019

St. Luke's - Roosevelt Hospital, New York

10461

Jacobi Medical Center, The Bronx

Montefiore Medical Center, The Bronx

17822

Geisinger Medical Center, Danville

19090

Abington Primary Women's Healthcare, Willow Grove

19140

Temple University Medical Center, Philadelphia

20910

Holy Cross Hospital, Silver Springs

21211

Johns Hopkins Community Physicians, Baltimore

23507

EVMS Maternal-Fetal Medicine, Hofheimer Hall, Norfolk

26506

West Virginia University, Morgantown

27103

Lyndhurst Gynecologic Associates, Winston-Salem

27834

Pitt County Memorial Hospital, Greenville

29605

University Medical Group, Dept of OB/GYN, Greenville

30342

Northside Maternal Fetal Specialists, Atlanta

31404

Memorial Health University Medical Center, Savannah

36604

University of South Alabama Department of OBGYN, Mobile

37403

Regional Obstetrical Consultants, Chattanooga

38120

Gynecology & Obstetrics, Memphis

40207

Maternal Fetal Medicine Norton Suburban Hospital, Louisville

40503

Central Baptist Hospital, Lexington

43606

The Toledo Hospital, Toledo

44146

Ohio Permanente Medical Group, Bedford

45219

University of Cincinnati, Cincinnati

60612

University of Illinois, Chicago

60637

University of Chicago, Chicago

63021

St. Louis University, St Louis

63110

Washington University, St Louis

70815

Maternal Fetal Medicine &Woman's Health Research, Baton Rouge

71103

Louisiana State University Health Sciences Center-Shreveport, Shreveport

75231

Health Central Women's Care, Dallas

77054

Clinical Research Center of Houston, Houston

78705

Womens Partner In Health, Austin

79430

Texas Tech University Health Sciences Center, Lubbock

79763

Texas Tech Health Sciences Center - Odessa, Odessa

80205

Kaiser Permanente, Denver

85712

Visions Clinical Research-Tucson, Tucson

87131

University of New Mexico, Albuquerque

90509

Harbor - UCLA Medical Center, Torrance

92123

SanDiego Perinatal Center, San Diego

92324

Women's Health Department, Colton

02115

Brigham and Women's Hospital, Boston

02135

St. Elizabeth's Medical Center -MFM, Brighton

08103

Cooper University Hospital, Camden

07039

Department of OBGYN, St. Barnabas Medical Center, Livingston

44104-5034

MacDonald Clinical Trials Unit, University Hospitals of Cleveland, Cleveland

Sponsors
All Listed Sponsors
lead

Juniper Pharmaceuticals, Inc.

INDUSTRY