Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

What Was Tested

This registered phase 1 trial tested Goserelin.

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

It had three arms (groups): Placebo (placebo comparator), Testosterone only (active comparator) and Testosterone and Estrogen (active comparator).

Placebo injection, gel and pill.

The registry classes the interventions as drug and other.

More on the Plan

There is evidence pointing to a relationship between insulin and testosterone in men (testosterone is the male sex hormone that is produced in the testes).

The purpose of this research study is to learn more about the details of the relationship between insulin and testosterone.

The researchers are looking for men between the ages of 50-75 with the metabolic syndrome to participate in this research study.

Participation in this study involves taking medication and/or placebo (a placebo looks exactly like the study medication but contains no active drug), blood tests, muscle biopsies, and imaging scans.

Who Took Part

The registry lists 66 actual participants took part.

It was open to men only aged from 50 years up to 75 years.

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

The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: no history of testicular disorders; no history of bleeding disorders (i.e. pulmonary embolism, deep vein thrombosis, stroke, hypercoagulable syndrome); no history of prostate cancer.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Goserelin.

It started in 2006-09 with completion listed for 2010-02-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Insulin sensitivity (time frame: 3 months).

It also tracked 4 secondary outcomes, for example Resting energy expenditure, Lipid profile, Body composition and Intramyocellular fat.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 66 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.