CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 308 enrolled
Drug / intervention
Testosterone Gel (Androgel) +1 moredrug
Likely dose
Testosterone Gel (Androgel) 7.5 gfrom 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/NCT00287586
NCT00287586Phase 4Completed

Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels

Brigham and Women's Hospital·interventional·Posted Feb 7, 2006·Updated Jun 29, 2017

In Brief

A Phase 4 clinical trial evaluating Testosterone Gel (Androgel) and Placebo for Hypogonadism and Atherosclerosis. Completed, enrolled 308 participants across 3 sites.

Detailed Summary

As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood. Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis. The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.

Study Details

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

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2006
Enrollment StartSep 1, 2004
Primary CompletionFeb 7, 2012
Study CompletionMay 12, 2012
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 20.4 years ago

Interventions

Testosterone Gel (Androgel)drug

7.5 g of 1% testosterone gel to achieve a nominal delivery of 75 mg testosterone daily for 3 years

Placebodrug

Placebo-matching testosterone gel daily for 3 years