NCT00957528

Cycled Testosterone Replacement Study

The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Male
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone	Weekly im injections of 100 mg testosterone enanthate.
DRUG	Placebo	Weekly IM injections of sesame oil.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2009-08-12
• Last updated: 2012-09-10
• Results posted: 2012-08-21

Locations

1 site across 1 country: United States