A Phase 4 interventional study of Letrozole and Placebo in Obesity, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to male participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Health services research
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.
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Letrozole
Drug: Placebo
One Letrozole 2.5 mg capsule every two days during four months
Also known as: Femara
One placebo capsule every two days during four months
cardiac function parameters
heart function will be measured by echocardiography.
Time frame: after 4 months intervention
Hepatic function parameters
Baseline sex steroids will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS) in fasting blood samples, before 10:00 am. Liver function will be analysed by a Nuclear Magnetic Resonance (NMR) recording
Time frame: before intervention
Hepatic function parameters
Baseline sex steroids will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS) in fasting blood samples, before 10:00 am. Liver function will be analysed by a Nuclear Magnetic Resonance (NMR) recording
Time frame: after 4 months intervention
cardiac function parameters
heart function will be measured by echocardiography.
Time frame: before intervention
glucose metabolism
Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).
Time frame: Before four months intervention.
weight
Time frame: Before intervention.
weight
Time frame: after four months intervention.
glucose metabolism
Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).
Time frame: Before intervention.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent