Conditions: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

Brief 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®

Detailed description:

Arms:
arm 1: Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections) arm 2: Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)

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: