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Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

NCT02940522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-04-28

Study results available
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Summary

To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.

Conditions

  • Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women

Interventions

DRUG

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

DRUG

Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Julie Krop, MD · AMAG Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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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 NCT02940522 on ClinicalTrials.gov