drugset / Trial / 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

NCT02937766

Phase 3 Terminated 60 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

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®

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator 17-alpha-hydroxyprogesterone caproate Unknown 250 mg/ml Subcutaneous

Indications

No indication recorded.