CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
17-OHPC +1 moredrug
Likely dose
17-OHPC 250 mgfrom 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/NCT00409825
NCT00409825Phase 2Completed
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A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy

University of Pittsburgh·interventional·Posted Dec 11, 2006·Updated Feb 27, 2015

In Brief

A Phase 2 clinical trial evaluating 17-OHPC and Blood Draws for Pregnancy. Completed, enrolled 61 participants across 4 sites.

Detailed Summary

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2006
Enrollment StartMar 1, 2006
Primary CompletionApr 1, 2008
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.6 years ago

Interventions

17-OHPCdrug

Intra-muscular injection of 250 mg 17-OHPC administered weekly between the second and third trimesters of pregnancy, until time of delivery.

Blood Drawsprocedure

10 cc of blood will be drawn prior to the fifth weekly administration of 17-OHPC during second trimester of pregnancy, and then once daily for seven consecutive days post-dose. 10 cc of blood also will be drawn prior to weekly administration of 17-OHPC from sixth weekly dose in the second trimester until the last scheduled dose in the third trimester. Prior to this last scheduled dose, 10 cc of blood will be drawn, as well as once daily for seven consecutive days post-dose.