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Vaginal Progesterone to Reduce the Risk of Another Preterm Birth

Information source: Juniper Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: 8% progesterone vaginal gel (Drug); Placebo Vaginal Gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Juniper Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
George W Creasy, MD, Study Director, Affiliation: VP Clinical Research; Columbia Laboratories, Inc

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Frequency of delivery <=32 weeks

Secondary outcome:

Frequency of delivery preterm

Response to tocolytic therapy

Number of infant hospital days from delivery to discharge

Detailed description: 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 "preemie")

- Patients must be 18-45 years of age

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. The subject has a history of a documented spontaneous singleton preterm delivery (hospital or clinic record, letter from healthcare provider, or birth certificate) from 20 0/7 to 35 0/7 weeks gestational age with the immediate preceding pregnancy or has a cervical length of 2. 5 cm or less measured by transvaginal ultrasound with the current pregnancy. "Spontaneous preterm delivery" is a delivery (<35 weeks), either vaginal or cesarean, that is initiated by either preterm PROM followed by contractions or preterm labor initiated with in-tact membranes. A previous preterm delivery secondary to an incompetent cervix where a cerclage is considered for this pregnancy is not considered a preterm delivery (please see Exclusion Criteria No. 10). Subjects enrolled based on a history of preterm delivery may have had a pregnancy loss (or losses) at <20 0/7 weeks gestational age between the preceding preterm delivery and the current pregnancy. 2. The female subject is between 18 and 45 years of age at the time of screening. 3. The pregnancy has an estimated gestational age between 16 0/7 weeks and 22 6/7 weeks. 4. The subject speaks either English or a common local language. 5. 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. 6. 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. Exclusion Criteria: 1. The subject has a previous history of an adverse reaction to progesterone or any component present in Prochieve® 8% vaginal gel. 2. The subject has been treated with a progestogen within the previous 4 weeks. 3. 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). 4. The subject has active thrombophlebitis or a thromboembolic disorder, or a history of hormone-associated thrombophlebitis or thromboembolic disorders. 5. The subject has liver dysfunction or disease. 6. The subject has known or suspected malignancy of the breast or genital organs. 7. 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. 8. The subject's current pregnancy is complicated by a major fetal anomaly or known chromosomal abnormality. 9. The subject has a uterine anatomic malformation (bicornuate uterus, septate uterus) 10. The subject has a multifetal gestation. 11. The subject has a cervical cerclage in place or has plans to have one placed during the current pregnancy. 12. The subject, in the judgment of the investigator, will be unable or unwilling to comply with study-related assessments and procedures. 13. The subject currently has preterm rupture of membranes, vaginal bleeding, known or suspected amnionitis, or signs or symptoms of preterm labor at the time of enrollment. 14. The subject is HIV positive with a CD4 count of _<350 cells/mm3 and is receiving more than 1 medication to prevent the transfer of AIDS to the fetus. 15. The subject has placenta previa or a low-lying placenta. The subject will be considered for the study if she is not at risk for increased bleeding and has not been given any vaginal precautions. 16. The subject's qualifying preterm delivery was an indicated delivery without preterm labor (i. e. delivery performed for fetal distress, maternal eclampsia/preeclampsia, fetal death, or amnionitis in the absence of contractions).

Locations and Contacts

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 Chicago, Chicago, Illinois 60637, United States

University of Illinois, Chicago, Illinois 60612, 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

Jacobi Medical Center, Bronx, New York 10461, United States

Montefiore Medical Center, Bronx, New York 10461, United States

St. Luke's - Roosevelt Hospital, New York, New York 10019, 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

Additional Information

Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial.

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.

Related 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.

Starting date: April 2004
Last updated: August 18, 2010

Page last updated: August 23, 2015

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