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
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier:
NCT00304213
First received: March 16, 2006
Last updated: March 20, 2006
Last verified: March 2006
  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 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
  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
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 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
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014