CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 137 enrolled
Drug / intervention
testosterone +1 moredrug
Likely dose
Not stated in 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/NCT01127659
NCT01127659Phase 4Completed
CompareCT.gov

Effect of Hypogonadotrophic Hypogonadism and Treatment With Testosterone on Insulin Sensitivity, Inflammation, Body Composition and Sexual Function in Obese and Type 2 Diabetic Men

University at Buffalo·interventional·Posted May 21, 2010·Updated Nov 29, 2022

In Brief

A Phase 4 clinical trial evaluating testosterone and placebo for Hypogonadism. Completed, enrolled 137 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2010
Enrollment StartMay 1, 2010
Primary CompletionMar 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.1 years ago

Interventions

testosteronedrug

intramuscular every 2 weeks

placebodrug

saline intramuscular every 2 weeks