MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

What Was Tested

This registered phase 4 trial tested Triptorelin for fatty liver & elevated liver enzymes.

It had two arms (groups): Triptorelin (active comparator) and orchiectomy (active comparator).

Androgen deprivation therapy by bilateral subcapsular orchiectomy.

The registry classes the interventions as drug and procedure.

More on the Plan

This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs.

Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to men only aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: implanted devices or foreign metallic bodies incompatible with magnetic resonance imaging; severe psychiatric disease.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-04 with completion listed for 2015-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in hepatic fat content (time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks).

It also tracked 2 secondary outcomes, for example Change in visceral/subcutaneous fat mass and Correlation between Hepatic fat content and baseline androgen status.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Triptorelin in 31 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, Fatty liver & elevated liver enzymes research.