drugset / Trial / NCT02097680

Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men

NCT02097680

Phase 4 Completed 30 enrolled University Hospital, Ghent
RandomizedParallel-groupTriple-blindHealth-services research

Summary

It seems plausible that increased aromatase activity in obese men, as a result of a larger fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition increases testosterone levels, which may affect hepatic and cardiac function. In this intervention study two groups of hypogonadal obese men are compared. Group A is treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a group with normal testosterone and low oestrogen concentrations. Group B is treated with placebo once every two days during four months; this group will retain low testosterone - and high oestrogenic concentrations. The primary objective of the study is to evaluate effects of changed sex steroids in obese men on hepatic and cardiac function.

Timeline

Start
2013-12
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Letrozole Other / unclassified 2.5 mg

Indications