CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled
Drug / intervention
LowT +3 moredrug
Likely dose
Low-dose testosterone gel 2.5 gm daily (target blood range 400-550 pg/ml) or high-dose testosterone gel 5.0 gm daily (two 2.5 gm packets, target blood range 600-1000 pg/ml) for 52 weeksAI-extracted
Key inclusion· 4
  • ✓Age 60 years or older
  • ✓Low-normal baseline testosterone 200-350 ng/dL
  • ✓Generally healthy and untrained
  • ✓Reside in Denver metro area
Key exclusion· 10
  • ✕History of prostate or breast cancer
  • ✕Severe obesity (BMI >34)
  • ✕Polycythemia
  • ✕Diabetes

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

Search/NCT00112151
NCT00112151Phase 2Completed
CompareCT.gov

Testosterone Supplementation and Exercise in Elderly Men

University of Colorado, Denver·interventional·Posted May 30, 2005·Updated Sep 2, 2020

In Brief

A Phase 2 clinical trial evaluating LowT, Resistance Training, and 2 other interventions for Healthy. Completed, enrolled 167 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2005
Enrollment StartJan 1, 2005
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 21.1 years ago

Interventions

LowTdrug

Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.

Resistance Trainingbehavioral

Weight training 45-60 minutes 3 times per week

Placebodrug

2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

HighTdrug

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.