NCT01004029

Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,740 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One of the most significant risk factors for preterm birth is previous pregnancy history. Women who have had a prior preterm birth have a 2.5-fold greater risk than women with no prior history of preterm birth. Prophylactic methods for prevention of preterm birth, including tocolytic drugs, bed rest, and other interventions such as cerclage, have been shown in most studies to be ineffective. One of the preventive measures that has shown effectiveness in randomized trials is the use of progesterone agents.9,10 Progesterone has been shown to support gestation and to inhibit uterine activity.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL	1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first.
DRUG	Vehicle	Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first.

Timeline

• Start date: 2009-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2009-10-29
• Last updated: 2022-06-01
• Results posted: 2021-01-28

Locations

104 sites across 9 countries: United States, Bulgaria, Canada, Czechia, Hungary, Italy, Russia, Spain, Ukraine