Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
Status:
Completed
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
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.