drugset / Trial / NCT00239590

Testosterone and Myocardial Perfusion in Coronary Heart Disease (CHD)

NCT00239590

Phase 2 Completed 28 enrolled Imperial College London Organon · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

Testosterone has traditionally been regarded as a risk factor for heart disease due to the fact that males have a higher incidence of this disease than women, at least until the menopause. However recent studies have shown that men with low levels of testosterone may be at an increased risk of developing coronary heart disease (furring up of the blood vessels supplying blood to the heart). Our group has demonstrated a relaxing effect of testosterone in isolated animal coronary arteries (blood vessels supplying blood to the heart). We have shown that short-term testosterone administration can increase coronary artery and brachial artery (blood vessel in the arm) blood flow and can decrease the lack of blood supply to the heart muscle in men with coronary artery disease. These findings indicate a need for similar but longer-term studies to investigate the possible beneficial effects of longer-term testosterone therapy on the heart and blood vessels. Should this treatment be shown to be beneficial to men with coronary artery disease it may be a useful additional therapy for men with the furring up of arteries in the heart and the resulting angina. Aim To investigate our hypothesis that testosterone can beneficially affect myocardial perfusion, vascular reactivity, metabolic risk factors for coronary heart disease and improve quality of life in men with low plasma testosterone levels and coronary heart disease.

Timeline

Start
2001-06
Primary completion
2004-04-24
Completion
2004-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Undecanoate Small molecule 80 mg Oral