TOM: Testosterone in Older Men With Sarcopenia

PHASE4TerminatedINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
SarcopeniaHypogonadismMuscular Diseases
Interventions
DRUG

Topical testosterone gel 1% (active formulation)

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.

DRUG

Topical gel (placebo formulation)

Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Trial Locations (2)

02118

Boston University Medical Center, Boston

02130

VA Boston Healthcare System (Jamaica Plain Campus), Boston

Sponsors
All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Boston Medical Center

OTHER