CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 800 enrolled
Drug / intervention
17P +1 moredrug
Likely dose
Not stated in 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/NCT03297216
NCT03297216Phase 3Completed
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Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy

University of North Carolina, Chapel Hill·interventional·Posted Sep 29, 2017·Updated Jul 22, 2021

In Brief

A Phase 3 clinical trial evaluating 17P and Placebo for Pre-term Birth and HIV-1-infection. Completed, enrolled 800 participants across 2 sites.

Detailed Summary

This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-term Birth, HIV-1-infection
CountriesZambia
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), AMAG Pharmaceuticals, Inc., Bill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 29, 2017
Enrollment StartFeb 7, 2018
Primary CompletionJun 25, 2020
Study CompletionAug 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.8 years ago

Interventions

17Pdrug

Synthetic progestin

Placeboother

Non-active placebo comparator