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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
Solvay Pharmaceuticals
Information provided by:
North Florida Foundation for Research and Education Identifier:
First received: March 16, 2006
Last updated: March 20, 2006
Last verified: March 2006

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
Drug: Testosterone
Phase 4

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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00304213

Contact: April Tilton, PA-C 386.984.7783
Contact: Thomas Mulligan, MD 352.374.6077

United States, Florida
Nf/Sg Vhs Recruiting
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
North Florida Foundation for Research and Education
Solvay Pharmaceuticals
Principal Investigator: Thomas Mulligan, MD Director, GRECC
  More Information

No publications provided 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:
Total testosterone < 300 ng/dL
Bioavailable testosterone < 70 ng/dL

Additional relevant MeSH terms:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2014