Does Testosterone Improve Function in Hypogonadal Older Men

NCT ID: NCT00304213

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Testosterone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

North Florida Foundation for Research and Education

OTHER

Sponsor Role lead

Principal Investigators

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Thomas Mulligan, MD

Role: PRINCIPAL_INVESTIGATOR

Director, GRECC

Locations

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Nf/Sg Vhs

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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79-06

Identifier Type: -

Identifier Source: org_study_id

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