CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Testosterone injection +2 moredrug
Likely dose
Testosterone injection 100 mgfrom 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/NCT00957801
NCT00957801Phase 4Completed

Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

The University of Texas Medical Branch, Galveston·interventional·Posted Aug 12, 2009·Updated May 8, 2018

In Brief

A Phase 4 clinical trial evaluating Testosterone injection, Testosterone gel, and 1 other intervention for Sarcopenia. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2009
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 16.9 years ago

Interventions

Testosterone injectiondrug

100 mg single IM injection

Testosterone geldrug

Testosterone gel 10 mg. administered topically daily for seven days

Medroldrug

Medrol 6 day dose pack with an additional 4mg dose on day 7