NCT02937766

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

A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
DRUG	Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Timeline

• Start date: 2016-10-07
• Primary completion: 2017-01-06
• Completion: 2017-03-27
• First posted: 2016-10-19
• Last updated: 2022-04-21
• Results posted: 2018-12-12

Locations

1 site across 1 country: United States