Does Testosterone Improve Function in Hypogonadal Older Men
Information source: North Florida Foundation for Research and Education
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: North Florida Foundation for Research and Education Official(s) and/or principal investigator(s):
Thomas Mulligan, MD, Principal Investigator, Affiliation: Director, GRECC
Overall contact:
April Tilton, PA-C, Phone: 386.984.7783, Email: april.tilton@va.gov
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.
Clinical Details
Official title: Does Testosterone Improve Function in Hypogonadal Older Men
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Physical functionCognitive function
Eligibility
Minimum age: 60 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
April Tilton, PA-C, Phone: 386.984.7783, Email: april.tilton@va.gov
NF/SG VHS, Gainesville, Florida 32608, United States; Recruiting
Additional Information
Starting date: March 2006
Ending date: April 2009
Last updated: March 20, 2006
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