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Does Testosterone Improve Function in Hypogonadal Older Men

This study has been withdrawn prior to enrollment.
(Study never started, PI relocation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304213
First Posted: March 17, 2006
Last Update Posted: February 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Solvay Pharmaceuticals
Information provided by:
North Florida Foundation for Research and Education
  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
Intervention Model: Parallel Assignment
Masking: Double
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304213


Locations
United States, Florida
Nf/Sg Vhs
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

ClinicalTrials.gov Identifier: NCT00304213     History of Changes
Other Study ID Numbers: 79-06
First Submitted: March 16, 2006
First Posted: March 17, 2006
Last Update Posted: February 13, 2015
Last Verified: February 2015

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents