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Systemic Hormones and Muscle Protein Synthesis

Plain-language guide to NCT03054168: phase 3 randomized trial of Goserelin, 34 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03054168
Phase
phase 3
Status
status unknown
Start
2016-12-15
Completion (planned or actual)
2018-11-15
Participants
34 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Sarcopenia; Muscle Hypotrophy; Muscle Atrophy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

It had four arms (groups): Old Testosterone trained (experimental), Old Placebo trained (placebo comparator), Young Zoladex trained (experimental) and Young placebo trained (placebo comparator).

8 old participants (65-75 years old) who will receive resistance exercise training and Placebo every two weeks.

The registry classes the interventions as drug and other.

More on the Plan

The function of skeletal muscle is best understood for its role in locomotion and providing mechanical support to the skeleton to facilitate movement.

However, skeletal muscles are also important for maintaining whole-body metabolic health.

For example, muscles also act as a site for glucose disposal thereby acting to maintain whole-body glycaemic control.

In addition, skeletal muscles represent a vast protein store, the amino acids from which can be used in times of fasting, infection and disease to provide energy to maintain other critical organs.

Who Took Part

The registry lists 34 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

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

The full record lists 0 inclusion and 31 exclusion criteria; among the exclusions: participation in a formal exercise regime; BMI \< 18 or \> 30 kg·m2; active cardiovascular disease:.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

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

Neither the participants nor the staff measuring them knew who was on Goserelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-12-15 with completion listed for 2018-11-15.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Muscle Protein Synthesis (time frame: 0-6 Weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 34 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.