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NCT00304213 Clinical Trial

Does Testosterone Improve Function in Hypogonadal Older Men

Hypogonadism Clinical Trial

Official title:
Does Testosterone Improve Function in Hypogonadal Older Men

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00304213
Other study ID # 79-06
Secondary ID
Status Withdrawn
Phase Phase 4
First received March 16, 2006
Last updated February 12, 2015
Start date March 2006
Est. completion date April 2009

Study information
Verified date February 2015
Source North Florida Foundation for Research and Education
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 60 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone

Locations
Country Name City State
United States Nf/Sg Vhs Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
North Florida Foundation for Research and Education Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physical function
Primary Cognitive function
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