Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
Condition: Preterm Birth · Sponsor: AMAG Pharmaceuticals, Inc.
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (104)
| Drug Research & Analysis Corporation | Montgomery, Alabama, United States | — |
| Tucson Medical Center (Watching Over Mothers and Babies Foundation) | Tucson, Arizona, United States | — |
| Grossmont Center for Clinical Research | La Mesa, California, United States | — |
| Naval Medical Center San Diego - Department of Obstetrics and Gynecology | San Diego, California, United States | — |
| Womens Health Specialists | West Hills, California, United States | — |
| Women's Associates, P.C. | Colorado Springs, Colorado, United States | — |
| Red Rocks OB/GYN - Physician's Research Options, LLC | Lakewood, Colorado, United States | — |
| Visions Clinical Research | Boynton Beach, Florida, United States | — |
| Palm Beach Obstetrics & Gynecology, PA (Altus Research) | Lake Worth, Florida, United States | — |
| Global OB/GYN Centers | Pembroke Pines, Florida, United States | — |
| New Millennium Obstetrics & Gynecology, LLc | Riverdale, Georgia, United States | — |
| Tripler Army Medical Center | Honolulu, Hawaii, United States | — |
+ 92 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT01004029