MedTrace Logo

17-OHPC in Pregnancy: IM vs SC Routes

NCT04183452 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2023-08-03

No results posted yet for this study

Summary

This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).

Conditions

Interventions

DRUG

17-Hydroxyprogesterone Caproate 250 mg IM Dose

17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

DRUG

17-Hydroxyprogesterone Caproate 275 mg SC Dose

17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Steve N. Caritis, MD

    lead OTHER

Principal Investigators

  • Steve N Caritis, MD · University of Pittsburgh-Magee Womens Hospital

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2023-04-06
Completion
2023-04-06
FDA Drug
Yes

Countries

  • United States

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 NCT04183452 on ClinicalTrials.gov