Conditions: Healthy
Keywords: Postmenopausal females Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.

Detailed description:

Arms:
arm 1: 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. arm 2: 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. arm 3: 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. arm 4: 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. arm 5: 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. arm 6: Placebo administered IV or SC once every 2 weeks for 8 weeks.

Interventions: intervention 1: LY2541546 - SC intervention 2: LY2541546 - IV intervention 3: Placebo - SC intervention 4: Placebo - IV
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered IV intervention 3: Administered SC intervention 4: Administered IV

Protocol document: