Adaptions and Resiliency to Multi-Stressor OpeRations

What Was Tested

This registered phase 4 trial tested Goserelin.

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits.

It had five arms (groups): CONTROL (men + women) (no intervention), STRESS (men + women): Multi-Stressor Training (active comparator), one (experimental), Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive Use (active comparator) and one (experimental).

The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.

The registry classes the interventions as drug and other.

More on the Plan

Suppression of the reproductive hypothalamic-pituitary-gonadal (HPG) axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age 18-40 years. Body mass index (BMI) 18-30 kg/m2. Weight stable (±10 lbs) in past 2 months. Takes part in moderate physical activity for at least 150 minutes/week. Currently free of upper or lower body /extremity injury or impairment.

The full record lists 9 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

In this single-blind Goserelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-07-15 with completion listed for 2027-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean (time frame: Through study completion, an average of 8 weeks). Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean (time frame: Through study completion, an average of 8 weeks). Biomechanical: Tendon Thickness, change from baseline and throughout training, mean (time frame: Through study completion, an average of 8 weeks).

It also tracked 4 secondary outcomes, for example Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean, Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean, Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean and Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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