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Does Testosterone Improve Function in Hypogonadal Older Men

Does Testosterone Improve Function in Hypogonadal Older Men

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00304213
Enrollment
0
Registered
2006-03-17
Start date
2006-03-31
Completion date
2009-04-30
Last updated
2015-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Keywords

hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL

Brief summary

This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age \> 60 years. The goal is to assess the safety and efficacy of TRT in men age \> 60 years.

Interventions

DRUGTestosterone

Sponsors

Solvay Pharmaceuticals
CollaboratorINDUSTRY
North Florida Foundation for Research and Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
60 Years to 80 Years

Inclusion criteria

age 60-80 yrs serum total testosterone \< 300 ng/dL serum bioavailable testosterone \< 70 ng/dL

Exclusion criteria

unable to provide informed consent history of prostate or breast cancer untreated sleep apnea

Design outcomes

Primary

MeasureTime frame
Physical function
Cognitive function

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026