Does Testosterone Improve Function in Hypogonadal Older Men

This study is currently recruiting participants.

Verified by North Florida Foundation for Research and Education, March 2006

First Received: March 16, 2006 Last Updated: March 20, 2006 History of Changes

Sponsors and Collaborators:	North Florida Foundation for Research and Education Solvay Pharmaceuticals
Information provided by:	North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier:	NCT00304213

Purpose

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.

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Does Testosterone Improve Function in Hypogonadal Older Men

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by North Florida Foundation for Research and Education:

Primary Outcome Measures:

Physical function
Cognitive function

Estimated Enrollment:	180
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2009

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304213

Contacts

Contact: April Tilton, PA-C	386.984.7783	april.tilton@va.gov
Contact: Thomas Mulligan, MD	352.374.6077	thomas.mulligan@med.va.gov

Locations

United States, Florida
NF/SG VHS	Recruiting
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

North Florida Foundation for Research and Education

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Thomas Mulligan, MD

Director, GRECC

More Information

No publications provided

Study ID Numbers:	79-06
Study First Received:	March 16, 2006
Last Updated:	March 20, 2006
ClinicalTrials.gov Identifier:	NCT00304213 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Florida Foundation for Research and Education:

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

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Hypogonadism
Endocrinopathy
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on August 24, 2009