CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,740 enrolled
Drug / intervention
Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL +1 moredrug
Likely dose
Hydroxyprogesterone Caproate Injection (HPC), 250mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01004029
NCT01004029Phase 3Completed
CompareCT.gov

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

AMAG Pharmaceuticals, Inc.·interventional·Posted Oct 29, 2009·Updated Jun 1, 2022

In Brief

A Phase 3 clinical trial evaluating Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL and Vehicle for Preterm Birth. Completed, enrolled 1,740 participants across 104 sites in 9 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Birth
CountriesBulgaria, Canada, Czechia, Hungary, Italy, Russia, Spain, Ukraine, United States
CollaboratorsResearchPoint Global

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 16.7 years ago

Interventions

Hydroxyprogesterone Caproate Injection (HPC), 250mg/mLdrug

1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.

Vehicledrug

Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.