NCT00304213

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

First QC Date

March 16, 2006

Last Update Submit

February 12, 2015

Conditions

Hypogonadism

Keywords

hypogonadismtestosteroneagingTotal testosterone < 300 ng/dLBioavailable testosterone < 70 ng/dL

Outcome Measures

Primary Outcomes (2)

  • Physical function

  • Cognitive function

Interventions

TestosteroneDRUG

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-80 yrs serum total testosterone \< 300 ng/dL serum bioavailable testosterone \< 70 ng/dL

You may not qualify if:

  • unable to provide informed consent history of prostate or breast cancer untreated sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nf/Sg Vhs

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Thomas Mulligan, MD

    Director, GRECC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

March 1, 2006

Study Completion

April 1, 2009

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

US(1)