Does Testosterone Improve Function in Hypogonadal Older Men

This study has been withdrawn prior to enrollment.
(Study never started, PI relocation)
Solvay Pharmaceuticals
Information provided by:
North Florida Foundation for Research and Education Identifier:
First received: March 16, 2006
Last updated: February 12, 2015
Last verified: February 2015
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

Enrollment: 0
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
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Please refer to this study by its identifier: NCT00304213

United States, Florida
Nf/Sg Vhs
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 Identifier: NCT00304213     History of Changes
Other Study ID Numbers: 79-06 
Study First Received: March 16, 2006
Last Updated: February 12, 2015
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
Physiological Effects of Drugs processed this record on May 30, 2016