Dose-Response of Gonadal Steroids and Bone Turnover in Older Men

What Was Tested

In this not phased trial, researchers set out to test Goserelin.

The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Group 5: 10* g/day (experimental).

Zoladex plus Placebo Testosterone (T) gel.

The registry classes the interventions as drug.

More on the Plan

In this protocol, men age 60-75 will be randomized to one of 6 groups.

Groups 1-5 will receive goserelin acetate (Zoladex) plus 0 (placebo gel), 1.25, 2.5, 5, or 10\* g/day of testosterone gel (Androgel).

Group 6 will receive placebos for both goserelin acetate and testosterone gel.

Subjects will be blinded with respect to group assignment.

Who Took Part

177 actual participants took part.

It was open to men only aged from 60 years up to 75 years.

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

Examples of who could join: Healthy men age 60 to 75.

The full record lists 1 inclusion and 22 exclusion criteria; among the exclusions: current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or paget's disease; cognitive or intellectual impairment that precludes complete understanding of the study protocol; history of deep vein thrombosis, pulmonary embolism, or clotting disorders.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

The Goserelin group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Goserelin was given.

Those kept unaware of assignments: participant.

It started in 2004-09 with completion listed for 2017-11-01.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Percent Change in Bone Turnover Marker (Serum C-telopeptide, CTX) (time frame: Baseline and 16 weeks).

It also tracked 4 secondary outcomes, for example Percentage Change in Body Composition: Fat Mass, Percentage Change in Thigh Muscle Area, Change in Erectile Function Symptoms and Change in Libido / Sexual Desire.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 177 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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