Testosterone and Neurovascular Control in Humans

What Was Tested

This registered not phased trial tested Cetrorelix.

The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.

It had two arms (groups): GnRH antagonist alone (experimental) and GnRH antagonist + Testosterone add-back (experimental).

Intervention: Cetrorelix acetate (Cetrotide).

Intervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel).

The registry classes the interventions as drug.

More on the Plan

Sex hormones play a pivotal role in neurovascular function in humans.

In recent years, great strides have been made in elucidating the roles of estrogen and progesterone on autonomic and vascular control in women; however, very little is known about the impact of testosterone in men.

Their current understanding of testosterone's effects on neurovascular control are confounded by numerous factors that independently alter autonomic and vascular function such as aging and chronic disease (e.g. cardiovascular disease, metabolic disease).

The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in young men to better isolate the effects of testosterone from the aforementioned confounding factors.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to men only aged from 18 years up to 35 years.

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

Examples of who could join: Free of chronic disease.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: congenital or acquired hypogonadism; drug/alcohol dependence; current smoker.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

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

It started in 2021-06 with completion listed for 2023-12.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Muscle sympathetic nerve activity (time frame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone). Endothelial function (time frame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone). Forearm blood flow (time frame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone).

It also tracked 1 secondary outcome, for example Skeletal muscle microvascular blood flow.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cetrorelix in 20 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 Cetrorelix compound page, all human trials.