Does Testosterone Improve Function in Hypogonadal Older Men

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2006 by North Florida Foundation for Research and Education. Recruitment status was Recruiting

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

Sponsor:	North Florida Foundation for Research and Education
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

ClinicalTrials.gov Identifier:	NCT00304213 History of Changes
Other Study ID Numbers:	79-06
Study First Received:	March 16, 2006
Last Updated:	March 20, 2006
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

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012