Conditions: Hypogonadism
Keywords: Low Normal Testosterone Male Aging
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.

Detailed description:
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.

Arms:
arm 1: Weekly placebo treatment for a duration of 5 months. arm 2: A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. arm 3: Weekly testosterone treatment for a duration of 5 months

Interventions: intervention 1: Testosterone intervention 2: Placebo
Intervention descriptions: intervention 1: Weekly im injections of 100 mg testosterone enanthate. intervention 2: Weekly IM injections of sesame oil.

Protocol document: