Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
Public ClinicalTrials.gov record NCT01004029. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3B, Multi-Center, Randomized, Double-Blind Study of Hydroxyprogesterone Caproate (HPC) Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01004029
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,740 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2009 (Actual)
- Primary completion
- Oct 2018 (Actual)
- Completion
- Oct 2018 (Actual)
- Last update posted
- Jun 1, 2022
2009 – 2018
United States locations
- U.S. sites
- 41
- U.S. states
- 23
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Drug Research & Analysis Corporation | Montgomery | Alabama | 36106 | — |
| Tucson Medical Center (Watching Over Mothers and Babies Foundation) | Tucson | Arizona | 85712 | — |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | — |
| Naval Medical Center San Diego - Department of Obstetrics and Gynecology | San Diego | California | 92134-5000 | — |
| Womens Health Specialists | West Hills | California | 91307 | — |
| Women's Associates, P.C. | Colorado Springs | Colorado | 80903 | — |
| Red Rocks OB/GYN - Physician's Research Options, LLC | Lakewood | Colorado | 80228 | — |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | — |
| Palm Beach Obstetrics & Gynecology, PA (Altus Research) | Lake Worth | Florida | 33407 | — |
| Global OB/GYN Centers | Pembroke Pines | Florida | 33024 | — |
| New Millennium Obstetrics & Gynecology, LLc | Riverdale | Georgia | 30274 | — |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | — |
| The Women's Clinic | Boise | Idaho | 83712 | — |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Women's Care Physicians/Obstetrical Specialists, PLLC | Louisville | Kentucky | 40207 | — |
| Steven Z. Lenowitz, MD, LLC | Bel Air | Maryland | 21014 | — |
| Female Pelvic Medicine and Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49503 | — |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Womack Army Medical Center | Fort Bragg | North Carolina | 28310 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Triad Research Partners, LLC | Winston-Salem | North Carolina | 27103 | — |
| Mid Dakota clinicl, PC Center for Women | Bismarck | North Dakota | 58501 | — |
| HWC Women's Research Center | Englewood | Ohio | 45322 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| SC Clinical Research Center, LLC | Columbia | South Carolina | 29201 | — |
| Greenville Hospital System University Medical Group | Greenville | South Carolina | 29605 | — |
| Women's Physician's Group, MPLLC | Memphis | Tennessee | 38104 | — |
| Practice Research Organization, Inc. | Dallas | Texas | 75230 | — |
| Carl R. Darnall Army Medical Center | Fort Hood | Texas | 76544 | — |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78236 | — |
| Research Associates Rio Grande Valley | McAllen | Texas | 78503 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Mt. Timpanogos Women's Health Care | Pleasant Grove | Utah | 84062 | — |
| Salt Lake Women's Center, P.C. | Sandy City | Utah | 84070 | — |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
| Wheaton Franciscan Healthcare - St. Joseph Campus | Milwaukee | Wisconsin | 53210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01004029, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01004029 live on ClinicalTrials.gov.