Influence of Male Hormones on Regional Fat Metabolism

What Was Tested

This registered phase 1 trial tested Leuprolide.

The male sex hormone, testosterone, plays an important role in determining body fat distribution in men.

This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity.

It had three arms (groups): Control Group (no intervention), Lupron Group (experimental) and Lupron & Testosterone Group (other).

Participants in this group will not receive any treatment.

Participants in this group will receive 7 weeks of leuprolide acetate (Lupron) treatment with testosterone gel (Androgel).

The registry classes the interventions as drug.

More on the Plan

There are 3 groups to which you might be assigned.

Assignment to these groups is random (ie. by flip of a coin).

If you are assigned to… * Group 1 - you will receive no treatments. * Group 2 - you will be given an injection of leuprolide acetate (Lupron) which will temporarily lower sex hormones.

The testosterone gel is rubbed on the upper shoulders, similar to putting on suntan lotion.

Who Took Part

39 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy, weight stable individuals. BMI 20-29 kg/m2.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: smoking and tobacco use.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2010-06 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Regional Fat Metabolism (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Leuprolide in 39 people.

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 Leuprolide compound page, all human trials.