Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy

What Was Tested

The trial (phase 4) is built around Goserelin.

To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand 2.

The registry classes the interventions as drug and procedure.

Who Took Part

10 actual participants took part.

It was open to men only aged from 20 years with no upper age limit.

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

Examples of who could join: Provision of informed consent. Males, age over 20 years, undesired fertility. Have positive family history of muscle weakness with these clinical signs:. Bulbar involvement (difficulty in breathing, swallowing, talking). Muscle atrophy with or without fasciculation.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: have weakness caused by other etiologies and have liver or kidney disease; have currently prostatic cancer; want to have a child.

How the Study Was Run

Design: randomized, single-group and open-label.

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.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-04 with completion listed for 2011-11.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): muscle power (time frame: every 3 months).

It also tracked 1 secondary outcome, for example electrophysiologic study (Nerve conduction and Electromyogram).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin in 10 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 Goserelin compound page, all human trials.