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Improving Pregnancy Outcomes With Progesterone

NCT03297216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2021-07-22

Study results available
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Summary

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

Conditions

Interventions

DRUG

17P

Synthetic progestin

OTHER

Placebo

Non-active placebo comparator

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jeff Stringer, MD, FACOG · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2020-06-25
Completion
2020-08-06
FDA Drug
Yes

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297216 on ClinicalTrials.gov