NCT02097680

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

Influence of the Aromatase Inhibitor Letrozole on Heart and Liver Function in Obese Men

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Letrozole	One Letrozole 2.5 mg capsule every two days during four months
DRUG	Placebo	One placebo capsule every two days during four months

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-03-27
• Last updated: 2022-01-24

Locations

1 site across 1 country: Belgium