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Does Testosterone Improve Function in Hypogonadal Older Men

Primary Purpose

Hypogonadism

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Testosterone

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)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

Sites / Locations

Nf/Sg Vhs

Outcomes

Primary Outcome Measures

Physical function

Cognitive function

Secondary Outcome Measures

Full Information

NCT ID

NCT00304213

First Posted

March 16, 2006

Last Updated

February 12, 2015

Sponsor

North Florida Foundation for Research and Education

Collaborators

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00304213

Brief Title

Does Testosterone Improve Function in Hypogonadal Older Men

Official Title

Does Testosterone Improve Function in Hypogonadal Older Men

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study never started, PI relocation

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

North Florida Foundation for Research and Education

Collaborators

Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypogonadism

Keywords

hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Testosterone

Primary Outcome Measure Information:

Title

Physical function

Title

Cognitive function

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Mulligan, MD

Organizational Affiliation

Director, GRECC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nf/Sg Vhs

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

12. IPD Sharing Statement

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Does Testosterone Improve Function in Hypogonadal Older Men

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