NCT02940522

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

A Multi-Center, Randomized, Open-Label Study 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-10-21
• Last updated: 2022-04-28
• Results posted: 2018-11-30

Locations

5 sites across 1 country: United States