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Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women

NCT02937766 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-21

Study results available
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Summary

To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®

Conditions

  • Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) 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

  • Neil Singla, MD · Lotus Clinical Research, LLC

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
2016-10-07
Primary Completion
2017-01-06
Completion
2017-03-27

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 NCT02937766 on ClinicalTrials.gov