Conditions: Sarcopenia Hypogonadism Muscular Diseases
Keywords: Andropause frailty hormone replacement therapy Aging
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 209
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Detailed description:
The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Topical testosterone gel 1% (active formulation) intervention 2: Topical gel (placebo formulation)
Intervention descriptions: intervention 1: Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. intervention 2: Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Protocol document: