drugset / Trial / NCT00131183

Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina

NCT00131183

RandomizedParallel-groupDouble-blindTreatment

Summary

This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia: * Does the anti-anginal effect persist long term? Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months. The investigators' earlier studies were limited to 3 months. * Does testosterone therapy in men affect the levels of measurable atheroma? There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma, although there is abundant evidence in animals to suggest a potential improvement. This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease. The primary endpoint is the change in time to ST- segment depression of \> 1mm during exercise testing.

Timeline

Start
2005-09
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Undecanoate Small molecule

Indications

No indication recorded.