Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery

Description

As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.

Study Start Date

October 2009

Estimated Completion Date

November 2018

Interventions

  • Drug: Hydroxyprogesterone Caproate Injection, 250mg/mL
  • Drug: Vehicle

Specialties

  • Obstetrics & Gynecology: Clinical Pharmacology,Maternal Fetal Medicine,Obstetrics,Preventive Medicine
  • Family Medicine: Clinical Pharmacology,Obstetrics
  • Pharmacy: Drug Trials,Pharmacokinetics

MeSH Terms

  • Pregnancy
  • Premature Birth

Study ID

KV Pharmaceutical Company -- 17P-ES-003

Status

Unknown

Trial ID

NCT01004029

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

1707

Sponsor

KV Pharmaceutical Company

Inclusion Criteria

    Each subject must meet the following criteria to be enrolled in this study: 1. Age >= 18 years. 2. Singleton gestation. 3. Project gestational age 16 weeks 0 days of gestation or more and less than or equal to 20 weeks 6 days of gestation at the time of randomization, based on clinical information and evaluation of the first ultrasound. 4. Documented history of a previous singleton spontaneous preterm delivery. Spontaneous preterm birth is defined as delivery from 20 weeks 0 days to 36 weeks 6 days of gestation following spontaneous preterm labor or pPROM. Where possible, the gestational age of the previous preterm birth (referred to as the qualifying delivery) should be determined as described in "Gestational Age Determination". If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the latest will be used. As a validation of the gestational age of the previous delivery, if the infant weighed more than 3300 grams (the birth weight 90th percentile for 36 weeks gestational age), this will not qualify as preterm. The previous preterm delivery cannot be an antepartum stillbirth.

Exclusion Criteria

    1. Multifetal gestation. 2. Known major fetal anomaly or fetal demise. An ultrasound examination between 14 weeks 0 days through 20 weeks 3 days of gestation must be performed to rule out fetal anomalies. 3. Progesterone treatment in any form (i.e., vaginal, oral, intramuscular) during current pregnancy. 4. Heparin therapy during current pregnancy or history of thromboembolic disease. 5. Maternal medical/obstetrical complications including:
  • Current or planned cerclage
  • Hypertension requiring medication
  • Seizure disorder 6. Subjects with a uterine anomaly (uterine didelphys or bicornate uterus). However, subjects with uterine fibroids are eligible for the study. 7. Unwillingness to comply with and complete the study. 8. A 14 weeks 0 days through 20 weeks 3 days of gestation ultrasound cannot be arranged before randomization. 9. Participation in an antenatal study in which the clinical status or intervention may influence gestational age at delivery. 10. Participation in this trial in a previous pregnancy. Women who were screened in a previous pregnancy, but not randomized, do not have to be excluded. 11. Known hypersensitivity to hydroxyprogesterone caproate or its components. 12. Have any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug including those listed in section 5.3.2 of the investigational brochure. Other examples to consider include uncontrolled diabetes, known HIV infection or renal dysfunction. 13. Have any significant medical disorder that, in the opinion of the investigator, would preclude accurate evaluation of the subject's condition or outcome in the study.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (74)

Study Location Distance Name Phone Email
NECCR of Massachusetts LLC HealthCare for Women Inc - New Bedford, Massachusetts 51.3 miles None None None
NECCR of Massachusetts LLC HealthCare for Women Inc - New Bedford, Massachusetts 51.3 miles None None None
University Hospital - Newark, New Jersey 195.9 miles None None None
Lawrence OBGYN Associates PC - Lawrenceville, New Jersey 236.7 miles None None None
Temple University School of Medicine - Philadelphia, Pennsylvania 266.2 miles None None None
Thomas Jefferson University Hospital - Philadelphia, Pennsylvania 269.5 miles None None None
Thomas Jefferson University Hospital - Philadelphia, Pennsylvania 269.5 miles None None None
Steven Z Lenowitz MD LLC - Bel Air, Maryland 337.3 miles None None None
Naval Medical Center Portsmouth - Portsmouth, Virginia 473.6 miles None None None
Naval Medical Center Portsmouth - Portsmouth, Virginia 473.6 miles None None None
Duke University Medical Center - Durham, North Carolina 608.4 miles None None None
Saginaw Valley Medical Research Group LLC - Saginaw, Michigan 655.5 miles None None None
Womack Army Medical Center - Fort Bragg, North Carolina 656.4 miles None None None
Womack Army Medical Center - Fort Bragg, North Carolina 656.4 miles None None None
Triad Research Partners LLC - Winston Salem, North Carolina 659.2 miles None None None
Lyndhurst Clinical Research - Winston-Salem, North Carolina 659.2 miles None None None
Lyndhurst Clinical Research - Winston-Salem, North Carolina 659.2 miles None None None
HWC Womens Research Center - Englewood, Ohio 711.3 miles None None None
Female Pelvic Medicine and Urogynecology Institute of Michigan - Grand Rapids, Michigan 741.6 miles None None None
SC Clinical Research Center LLC - Columbia, South Carolina 791.5 miles None None None
Greenville Hospital System University Medical Group - Greenville, South Carolina 803.9 miles None None None
Greenville Hospital System University Medical Group - Greenville, South Carolina 803.9 miles Kenneth Trofatter MD 864-455-1600 ktrofatter@ghs.org
Womens Care PhysiciansObstetrical Specialists PLLC - Louisville, Kentucky 818.4 miles None None None
Womens Care PhysiciansObstetrical Specialists PLLC - Louisville, Kentucky 818.4 miles None None None
University of Louisville - Louisville, Kentucky 823.2 miles Stanley Gall MD 502-561-7447 sagall@louisville.edu
University of Louisville - Louisville, Kentucky 823.2 miles None None None
Wheaton Franciscan Healthcare St Joseph Campus - Milwaukee, Wisconsin 858.7 miles None None None
Wheaton Franciscan Healthcare St Joseph Campus - Milwaukee, Wisconsin 858.7 miles Menachem Graupe MD 414-259-7480 graupe@ieee.org
Obstetrical and Gynecological Care - Savannah, Georgia 900.5 miles None None None
Obstetrical and Gynecological Care - Savannah, Georgia 900.5 miles None None None
New Millennium Obstetrics Gynecology LLc - Riverdale, Georgia 946.7 miles None None None
Washington University School of Medicine - St. Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine - St. Louis, Missouri 1,039.5 miles None None None
SLUCare Ob Gyn Clinic - St. Louis, Missouri 1,042.3 miles None None None
Drug Research Analysis Corporation - Montgomery, Alabama 1,082.3 miles None None None
Womens Physicians Group MPLLC - Memphis, Tennessee 1,133.9 miles None None None
Womens Medical Research Group - Clearwater, Florida 1,191.4 miles None None None
Womens Medical Research Group - Clearwater, Florida 1,191.4 miles None None None
Palm Beach Obstetrics Gynecology PA Altus Research - Lake Worth, Florida 1,194.5 miles None None None
Visions Clinical Research - Boynton Beach, Florida 1,197.4 miles None None None
Global OBGYN Centers - Pembroke Pines, Florida 1,246.1 miles None None None
Mid Dakota clinicl PC Center for Women - Bismarck, North Dakota 1,486.7 miles None None None
Mid Dakota clinicl PC Center for Women - Bismarck, North Dakota 1,486.7 miles None None None
Practice Research Organization Inc - Dallas, Texas 1,546.2 miles None None None
Carl R Darnall Army Medical Center - Fort Hood, Texas 1,661.0 miles None None None
San Antonio Military Medical Center - Fort Sam Houston, Texas 1,774.1 miles None None None
San Antonio Military Medical Center - Fort Sam Houston, Texas 1,774.1 miles None None None
Red Rocks OBGYN Physicians Research Options LLC - Lakewood, Colorado 1,777.0 miles None None None
Womens Associates PC - Colorado Springs, Colorado 1,778.5 miles None None None
Womens Associates PC - Colorado Springs, Colorado 1,778.5 miles None None None
Research Associates Rio Grande Valley - McAllen, Texas 1,902.3 miles None None None
Rosemark Women Care Specialists - Idaho Falls, Idaho 2,055.7 miles None None None
Rosemark Women Care Specialists - Idaho Falls, Idaho 2,055.7 miles Jeffrey B Baker MD 208-557-2900 jbbaker@cableone.net
Mt Timpanogos Womens Health Care - Pleasant Grove, Utah 2,096.5 miles None None None
Tanner Clinic - Layton, Utah 2,096.6 miles None None None
Salt Lake Womens Center PC - Sandy, Utah 2,100.2 miles None None None
Salt Lake Womens Center PC - Sandy, Utah 2,100.2 miles None None None
The Womens Clinic - Boise, Idaho 2,256.8 miles None None None
The Womens Clinic - Boise, Idaho 2,256.8 miles Kerry Lowder MD 208-947-9816 bklowder@hotmail.com
Tucson Medical Center Watching Over Mothers and Babies Foundation - Tucson, Arizona 2,277.9 miles None None None
Tucson Medical Center Watching Over Mothers and Babies Foundation - Tucson, Arizona 2,277.9 miles None None None
Womens Health Research - Phoenix, Arizona 2,298.4 miles None None None
Madigan Army Medical Center - Tacoma, Washington 2,507.4 miles None None None
Madigan Army Medical Center - Tacoma, Washington 2,507.4 miles Jason Pates MD 253-968-3920 jason.pates.mil@mail.mil
Oregon Health and Science University - Portland, Oregon 2,538.3 miles None None None
Oregon Health and Science University - Portland, Oregon 2,538.3 miles None None None
North Coast Womens Care Medical Group Inc - Vista, California 2,571.4 miles None None None
Grossmont Center for Clinical Research - La Mesa, California 2,573.5 miles None None None
Grossmont Center for Clinical Research - La Mesa, California 2,573.5 miles None None None
SouthBay Clinical Trials - Rancho Palos Verdes, California 2,610.2 miles None None None
SouthBay Clinical Trials - Rancho Palos Verdes, California 2,610.2 miles None None None
Womens Health Specialists - West Hills, California 2,611.9 miles None None None
Womens Health Specialists - West Hills, California 2,611.9 miles None None None
Tripler Army Medical Center - Honolulu, Hawaii 5,090.1 miles None None None

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