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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Lumara Health, Inc.
Sponsor:
Collaborator:
ResearchPoint Global
Information provided by (Responsible Party):
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT01004029
First received: October 27, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Preterm Birth
Drug: Hydroxyprogesterone Caproate Injection, 250mg/mL
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery

Resource links provided by NLM:


Further study details as provided by Lumara Health, Inc.:

Primary Outcome Measures:
  • Determine if treatment with 17P reduces the rate of preterm birth < 35 weeks, 0 days of gestation in women with a previous singleton spontaneous preterm delivery. [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Co-primary endpoint #1

  • Determine if 17P reduces the rate of neonatal mortality or morbidity [ Time Frame: 28 days of life or discharge from the NICU ] [ Designated as safety issue: Yes ]
    Co-primary endpoint #2 Neonatal mortality or morbidity is measured by a composite index comprised of: Neonatal death, Grade 3 or 4 intraventricular hemorrhage, Respiratory distress syndrome, Bronchopulmonary dysplasia, Necrotizing enterocolitis, Proven sepsis


Secondary Outcome Measures:
  • Exclude a doubling of the risk of fetal/early infant death [ Time Frame: Delivery ] [ Designated as safety issue: Yes ]
    Defined as spontaneous abortion/miscarriage (delivery from 16 weeks 0 days through 19 weeks 6 days of gestation) or neonatal death occurring in liveborns born at less than 24 weeks gestation or stillbirth (antepartum or intrapartum death from 20 weeks gestation through term), in the 17P group compared to the vehicle group

  • Preterm birth prior to 32 weeks 0 days of gestation [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Preterm birth prior to 37 weeks 0 days of gestation [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal death (from minutes after birth until 28 days of life) occurring in liveborns born at 24 weeks gestation or greater [ Time Frame: 28 days of life or discharge from the NICU ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1707
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle
Inert Oil
Drug: Vehicle
Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Other Name: Placebo
Active Comparator: Hydroxyprogesterone Caproate Injection, 250 mg/mL
HPC 250 mg/mL in oil
Drug: Hydroxyprogesterone Caproate Injection, 250mg/mL
1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
Other Names:
  • Makena
  • 17P

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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, other than micronized progesterone delivered orally or vaginally provided it is stopped at least 4 weeks prior to the first dose of study medication.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004029

Contacts
Contact: Robert Birch, PhD 314-645-6600 ext 3405 rbirch@lumarahealth.com
Contact: Debbie Heuvelman 314-645-6600 DHeuvelman@lumarahealth.com

  Hide Study Locations
Locations
United States, Alabama
Drug Research & Analysis Corporation Terminated
Montgomery, Alabama, United States, 36106
United States, Arizona
Women's Health Research Withdrawn
Phoenix, Arizona, United States, 85015
Tucson Medical Center (Watching Over Mothers and Babies Foundation) Recruiting
Tucson, Arizona, United States, 85712
Contact: Hugh Miller, MD    520-795-8188    hmiller1@email.arizona.edu   
United States, California
Grossmont Center for Clinical Research Completed
La Mesa, California, United States, 91942
SouthBay Clinical Trials Withdrawn
Rancho Palos Verdes, California, United States, 90275
Naval Medical Center San Diego - Department of Obstetrics and Gynecology Terminated
San Diego, California, United States, 92134-5000
North Coast Women's Care Medical Group, Inc. Withdrawn
Vista, California, United States, 92083
Womens Health Specialists Terminated
West Hills, California, United States, 91307
United States, Colorado
Women's Associates, P.C. Completed
Colorado Springs, Colorado, United States, 80903
Red Rocks OB/GYN - Physician's Research Options, LLC Completed
Lakewood, Colorado, United States, 80228
United States, Florida
Visions Clinical Research Completed
Boynton Beach, Florida, United States, 33472
Women's Medical Research Group Withdrawn
Clearwater, Florida, United States, 33759
Palm Beach Obstetrics & Gynecology, PA (Altus Research) Recruiting
Lake Worth, Florida, United States, 33407
Contact: Sylvia Siegfried, MD    561-641-0404    ssiegfried@altusresearch.com   
Global OB/GYN Centers Completed
Pembroke Pines, Florida, United States, 33024
United States, Georgia
New Millennium Obstetrics & Gynecology, LLc Completed
Riverdale, Georgia, United States, 30274
Obstetrical and Gynecological Care Withdrawn
Savannah, Georgia, United States, 31404
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Christina Hill, MD    808-433-5184    christina.hill1@us.army.mil   
United States, Idaho
The Women's Clinic Recruiting
Boise, Idaho, United States, 83712
Contact: Kerry Lowder, MD    208-947-9816    bklowder@hotmail.com   
Rosemark Women Care Specialists Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Jeffrey B Baker, MD    208-557-2900    jbbaker@cableone.net   
United States, Kentucky
Women's Care Physicians/Obstetrical Specialists, PLLC Terminated
Louisville, Kentucky, United States, 40207
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Stanley Gall, MD    502-561-7447    sagall@louisville.edu   
United States, Maryland
Steven Z. Lenowitz, MD, LLC Recruiting
Bel Air, Maryland, United States, 21014
Contact: Steven Z Lenowitz, MD    410-838-2000    stevezl@aol.com   
United States, Massachusetts
NECCR of Massachusetts, LLC - HealthCare for Women, Inc. Withdrawn
New Bedford, Massachusetts, United States, 02740
United States, Michigan
Female Pelvic Medicine and Urogynecology Institute of Michigan Completed
Grand Rapids, Michigan, United States, 49503
Saginaw Valley Medical Research Group, LLC Recruiting
Saginaw, Michigan, United States, 48604
Contact: Thomas Minnec, MD    989-497-5838    tminnec@womensob.com   
United States, Missouri
SLUCare Ob Gyn Clinic Withdrawn
St. Louis, Missouri, United States, 63117
Washington University School of Medicine Completed
St. Louis, Missouri, United States, 63110
United States, New Jersey
Lawrence OB-GYN Associates, P.C. Withdrawn
Lawrenceville, New Jersey, United States, 08648
University Hospital Withdrawn
Newark, New Jersey, United States, 07103
United States, North Carolina
Duke University Medical Center Completed
Durham, North Carolina, United States, 27705
Womack Army Medical Center Completed
Fort Bragg, North Carolina, United States, 28310
Triad Research Partners, LLC Completed
Winston Salem, North Carolina, United States, 27103
Lyndhurst Clinical Research Completed
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Mid Dakota clinicl, PC Center for Women Suspended
Bismarck, North Dakota, United States, 58501
United States, Ohio
HWC Women's Research Center Completed
Englewood, Ohio, United States, 45322
United States, Oregon
Oregon Health and Science University Withdrawn
Portland, Oregon, United States, 97239
United States, Pennsylvania
Temple University School of Medicine Completed
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University Hospital Completed
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
SC Clinical Research Center, LLC Completed
Columbia, South Carolina, United States, 29201
Greenville Hospital System University Medical Group Recruiting
Greenville, South Carolina, United States, 29605
Contact: Kenneth Trofatter, MD    864-455-1600    ktrofatter@ghs.org   
United States, Tennessee
Women's Physician's Group, MPLLC Terminated
Memphis, Tennessee, United States, 38104
United States, Texas
Practice Research Organization, Inc. Completed
Dallas, Texas, United States, 75230
Carl R. Darnall Army Medical Center Completed
Fort Hood, Texas, United States, 76544
San Antonio Military Medical Center Completed
Fort Sam Houston, Texas, United States, 78236
Research Associates Rio Grande Valley Completed
McAllen, Texas, United States, 78503
United States, Utah
Tanner Clinic Recruiting
Layton, Utah, United States, 84041
Contact: Steven L Johnson, MD    801-773-4840 ext 3741    sjohnson@tannerclinic.com   
Mt. Timpanogos Women's Health Care Completed
Pleasant Grove, Utah, United States, 84062
Salt Lake Women's Center, P.C. Completed
Sandy, Utah, United States, 84070
United States, Virginia
Naval Medical Center - Portsmouth Completed
Portsmouth, Virginia, United States, 23708
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Jason Pates, MD    253-968-3920    jason.pates.mil@mail.mil   
United States, Wisconsin
Wheaton Franciscan Healthcare - St. Joseph Campus Recruiting
Milwaukee, Wisconsin, United States, 53210
Contact: Menachem Graupe, MD    414-259-7480    graupe@ieee.org   
Canada, Alberta
University of Calgary - Foothills Hospital Recruiting
Calgary, Alberta, Canada, AB T2N 2T9
Contact: Stephen Wood, MD    403-944-2017    stephen.wood@albertahealthservices.com   
Canada, British Columbia
Royal Columbian Hospital Withdrawn
New Westminister, British Columbia, Canada, V3L 3W7
Lion's Gate Hospital (University of BC) Terminated
North Vancouver, British Columbia, Canada, V7M 2H5
Canada, Ontario
Glazier Medical Centre Completed
Oshawa, Ontario, Canada, L1H2J9
The Ottawa Hospital, General Campus Completed
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre Withdrawn
Toronto, Ontario, Canada, M4N 3M5
J. Leung Obstetrics and Gynaecology Completed
Windsor, Ontario, Canada, N8X 3V6
Victory Reproductive Care Recruiting
Wndsor, Ontario, Canada, N8W 5R7
Contact: Rahi Victory, MD    519-944-6400    rahivictory@yahoo.com   
Czech Republic
Nemocnice Ceske Budejovice, a.s. Gynekologicko-pordnicka klinika Completed
Ceske Budejovice 7, Czech Republic, 37001
Fakultni nemocnice Hradec Kralove Porodnicka a gynekologicka klinika Terminated
Hradec Kralove, Czech Republic, 500 05
Fakultni nemocnice Ostrava Porodnicko-gynekologicka klinika Terminated
Ostrava-Poruba, Czech Republic, 70852
Fakultni nemocnice Pizen Gynekologicko-pordnicka klinika Withdrawn
Plzen-Lochotin, Czech Republic, 304 60
Maternigy Hospital Podoli Withdrawn
Praha 4-Podoli, Czech Republic, 147 00
Hungary
Honvedkorhaz Allami Egeszsegugyi Kozpont Szuleszet Nogyogyaszat Withdrawn
Budapest, Hungary, 1134
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet, Szuleszet - Nogyogyaszat Recruiting
Budapest, Hungary, 1097
Contact: Pal Siklos, MD    +3614555700    siklos10@t-online.hu   
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum, Szuleszeti es Nogyogyaszati Klinika Recruiting
Debrecen, Hungary, 4032
Contact: Zoltan Toth, MD    +3652417171    ztoth@med.unideb.hu   
Petz Aladar Megyei Oktato Korhaz, Szuleszet-Nogyogyaszat Recruiting
Gyor, Hungary, 9024
Contact: Sandor Nagy, MD    +36964182441188    nagysandor@petz.gyor.hu   
Bacs-Kiskun Megyei Onkormanyzat Korhaza, Svegedi Tudmanyegyetem Altalanos Orvostudomanyi kar Oktato Korhaza Recruiting
Kecskemet, Hungary, 6000
Contact: Balazs Biro, MD    +3676516922    birob@kmk.hu   
Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft. Recruiting
Nyiregyhaza, Hungary, 4400
Contact: Karoly Pap, MD    +3642462247    papka@josa.hu   
Pecsi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika Withdrawn
Pecs, Hungary, 17
Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika Recruiting
Szeged, Hungary, 6725
Contact: Attila Pal, MD    +3662545757    palattila@obgyn.szote.u-szeged.hu   
Italy
Azienda Ospedaliera di Perugia Completed
Sant' Andrea della Fratte, Perugia, Italy, 06132
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi Completed
Bologna, Italy, 40100
Azienda Ospedaliera di Bolzano Ospedale Generale Regionale di Bolzano Completed
Bolzano, Italy, 39100
Azienda Ospedaliera "Ospedal di Lecco" Withdrawn
Lecco, Italy, 23900
Russian Federation
Northern State Medical University Recruiting
Arkhangelsk, Russian Federation
Contact: Alexey Baranov    +78182275631    albar@atnet.ru   
Belgorod Regional Clinical Hospital of St.Ioasaf Recruiting
Belgorod, Russian Federation
Contact: Vladimir Kulikovskiy, MD    +78722504900    okb@bel.ru   
Federal State Institution "Ivanovo V.N. Gorodkov Research Institute of Maternity and Childhood of Rosemedtechnologies" Withdrawn
Ivanovo, Russian Federation, 153731
State Educational Institution of Higher Professional Education "Kazan State Medical University of RosZdrav" Recruiting
Kazan, Russian Federation, 420012
Contact: IIdar Fatkullin, MD    +78435214079    fatkullin@yandex.ru   
Kemerovo State Medical Academy Recruiting
Kemerovo, Russian Federation
Contact: Natalia Artymuk    +73842392215    roddom_kokb@mail.ru   
State Educational Institution of Higher Professional Education "Krasnoyarsk State University named After Prof. V.F. Voino-Yasenetsky of Ministry of Health Russia" Department of Perinatology, Obstetrics and Gynecology of Medical Faculty Recruiting
Krasnoyarsk, Russian Federation, 660100
Contact: Vitaliy Tskhay, MD    +89232872134    tchai@yandex.ru   
State Educational Institution of Higher Professional Education "People's Friendship University of Russia" Department of Obstetrics and Gynecology with Course Perinatology Recruiting
Moscow, Russian Federation, 117333
Contact: Viktor Radzinsky, MD    +74951374881    radzinsky@yandex.ru   
Russian National Research Medical University named after N.I. Pirogov Recruiting
Moscow, Russian Federation
Contact: Yulia Dobrokhotova, MD    +74992374033    lis9@rambler.ru   
Municipal Healthcare Institution "Novosibirsk Municipal Perinatal Centre" Recruiting
Novosibirsk, Russian Federation, 630089
Contact: Oleg Pekarev, MD    +73832679311    ogpekarev@online.nsk.su   
State Educational Institution of Higher Professional Education "Rostov State Medical University of RosZdrav" Withdrawn
Rostov-on-Don, Russian Federation, 344029
Almazov Federal Heart, Blood and Endocrinology Centre Recruiting
Saint Petersburg, Russian Federation
Contact: Alexey IIyin, MD    +78127026855    a_ilyin@inbox.ru   
State Institution "D.O. Otto Scientific Institute for Obstetrics and Gynecology" Recruiting
St. Petersburg, Russian Federation, 199034
Contact: Marina Tarasova, MD    +7823289824    tarasova@mt9956.spb.edu   
State Educational Institution of Higher Professional Education "St. Petersburg l.l Mechnikov State Medical Academy of RosZdrav" Department of Obstetrics, Gynecology and Perinatology Recruiting
St. Petersburg, Russian Federation, 195257
Contact: Nina Tatarova, MD    +78125550906    tatarova@mail.ru   
Regional Perinatal Center Recruiting
Tomsk, Russian Federation
Contact: Vladimir Udut, MD    +79822418892    udutv@mail.ru   
State Healthcare Institution "Regional Maternity Hospital" Suspended
Yaroslavl, Russian Federation, 150003
Federal State Institution "Ural Research Institute of Maternity and Infancy Care of Rosmedtechnologies" Recruiting
Yekaterinburg, Russian Federation, 620028
Contact: Nadezhda Bashmakova, MD    +73433718768    dr@omm.ru   
Spain
Hospital Universitari Vall D'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Luis Cabero Roura, MD    +34934893084    lcaberor@meditex.es   
Hospital Universitario Puerta del Mar Completed
Cadiz, Spain, 11009
Hospital Universitario Materno Infantil de Canarias Recruiting
La Palmas de Gran Canarias, Spain, 35016
Contact: Jose Garcia Hernandez, MD    +34928444830    jgarderd@gobiernodecanarias.org   
Hospital 12 de Octubre Recruiting
Madrid, Spain
Contact: Alberto Galindo Izquierdo, MD    +34913908310    agalindo.hdoc@gmail.com   
Hospital Puerta de Hierro Recruiting
Madrid, Spain
Contact: Francisco Lopez Sanchez, MD    +34911916481    fralosanchez@gmail.com   
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Jose Luis Bartha, MD    34917277207    joseluis.bartha@uca.es   
Hospital Virgen Del Rocio Recruiting
Sevilla, Spain
Contact: Lucas Angel Cerrillos Gonzalez, MD    +34955012701    lucas.cerrillos.sspa@juntadeandalucia.es   
Hospital Universitario La Fe Recruiting
Valencia, Spain, 46009
Contact: Luis Perales, MD    34961245842    perales_alf@gva.es   
"Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Jose Manuel Campillos Maza, MD    +34 976-765-483    jmcampillos@salud.aragon.es   
Ukraine
City Clinical Maternity Hospital #1 Recruiting
Chernivtsi, Ukraine
Contact: Oleksandr Yuzko, MD    +380506752334    reprod.cv@gmail.com   
Donets'k Regional Centre of Mother and Child Care Recruiting
Donets'k, Ukraine, 83114
Contact: Valentyna Kvashenko, MD    +380503682495    fp.kvashenko@gmail.com   
Ivano-Frankivs'k Regional Prenatal Center, department of pregnant pathology Recruiting
Ivano-Frankivs'k, Ukraine
Contact: Oksana Makarchuk, MD    +380505210192    o_makarchuk@ukr.net   
<<Institute of Pediatrics, Obstetrics and Gynecology of AMS Ukraine>> Department of Rehabilitation and Reproduktive function of Women Recruiting
Kyiv, Ukraine, 04050
Contact: Alla Kornatska, MD    +380509238077    alla.kornatska@gmail.com   
Kyiv City Centre of Reproduction and perinatal medicine, obstetric department Recruiting
Kyiv, Ukraine
Contact: Vyacheslav Kaminskyy, MD    +380444119233    kagir@ukr.net   
SI "Institute of pediatrics, obstetrics and gynecology of AMS of Ukraine". Department of extragenital pathology and postnatal rehabilitation Recruiting
Kyiv, Ukraine
Contact: Tetyana Tatarchuk    +380442792156    prof.tatarchuk@gmail.com   
Polyclinic #1, Obolon district of Kyiv, maternity welfare department Recruiting
Kyiv, Ukraine, 04220
Contact: Natalia Potapenko, MD    +380444265404    gmnozh@gmail.com   
Lugansk State Medical University Recruiting
Lugansk, Ukraine
Contact: Vasyl Simrok, MD    +380503262858    partus7@yandex.ru   
Municipal Institution "Maternity Hospital #1" Recruiting
Odessa, Ukraine, 65039
Contact: Iryna Davydova, MD    +380973747101    davydova1967@gmail.com   
Crimea State Medical University namded after S. I. Georgiesky Recruiting
Simferopil, Ukraine, 95017
Contact: Vitaliy Zabolotnov, MD    +380504872444    vaz@crimea.com   
Ternopil' Municipal Hospital # 2 Recruiting
Ternopil, Ukraine, 46001
Contact: alla Boychuk, MD    +380673025808    boychuck-alla@rambler.ru   
Uzhgorod Municipal prenatal Centre, maternity welfare department #2 Recruiting
Uzhgorod, Ukraine, 88017
Contact: Ivan Treschak, MD    +380505732939    itreschak@mail.ru   
Clinical Maternity Hospital No 4 Recruiting
Zaporizhzhya, Ukraine, 69065
Contact: Galina Reznichenko, MD    +380974596333    reznichenkog@mail.ru   
Department of Obstetrics and Gynecology of Zhaporizhzhya Medical Academy of Postgraduate Education on the Base of Healthcare Institution Maternity Hospital No 3 Recruiting
Zhaporizhzhya, Ukraine, 69071
Contact: Nataliya Lutsenko, MD    +380676128504    vena03@ukr.net   
Sponsors and Collaborators
Lumara Health, Inc.
ResearchPoint Global
Investigators
Study Director: Robert Birch, PhD Lumara Health, Inc.
  More Information

No publications provided

Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT01004029     History of Changes
Other Study ID Numbers: 17P-ES-003
Study First Received: October 27, 2009
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lumara Health, Inc.:
17P
hydroxyprogesterone caproate
preterm birth
progesterone
women with a singleton pregnancy
aged 18 years or older
with a history of a previous singleton spontaneous preterm delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins
Hormones

ClinicalTrials.gov processed this record on August 28, 2014