At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 enrolled
Drug / intervention
17-Hydroxyprogesterone Capronatedrug
Likely dose
17-Hydroxyprogesterone Capronate 250mgfrom 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.
Impact of a Higher Dose on the Pharmacokinetics of 17-alpha Hydroxyprogesterone Caproate in Obese Women
In Brief
A Phase 3 clinical trial evaluating 17-Hydroxyprogesterone Capronate for Premature Birth and Absorption; Chemicals. Completed, enrolled 44 participants across 2 sites.
Detailed Summary
Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth, Absorption; Chemicals
CountriesUnited States
CollaboratorsWashington University School of Medicine
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedFeb 2018
Primary CompletionJun 2021
Study CompletionJul 2021
TodayJul 2026
First PostedFeb 14, 2018
Enrollment StartAug 23, 2017
Primary CompletionJun 1, 2021
Study CompletionJul 14, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.4 years ago
Interventions
17-Hydroxyprogesterone Capronatedrug
17-Hydroxyprogesterone Capronate 250mg versus 500mg