CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Testosterone Transdermal System (Androderm 5 mg patch)drug
Likely dose
Testosterone Transdermal System (Androderm 5 mg patch)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00266864
NCT00266864Phase 3Completed

Testosterone Replacement Therapy in Chronic Spinal Cord Injury

VA Office of Research and Development·interventional·Posted Dec 19, 2005·Updated Nov 1, 2017

In Brief

A Phase 3 clinical trial evaluating Testosterone Transdermal System (Androderm 5 mg patch) for Spinal Cord Injury and Hypogonadism. Completed, enrolled 31 participants across 2 sites.

Detailed Summary

It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on: body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2005
Enrollment StartAug 1, 2003
Primary CompletionAug 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 20.5 years ago

Interventions

Testosterone Transdermal System (Androderm 5 mg patch)drug

Testosterone Transdermal System (Androderm 5 mg patch)