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This study has been withdrawn prior to enrollment.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

No publications provided 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
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015