Conditions: Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: yes

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

Detailed description:

Arms:
arm 1: Subcutaneous (SQ) injection using an autoinjector arm 2: Intramuscular injection (IM) using syringe and needle

Interventions: intervention 1: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) intervention 2: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: