Current partner codePEPTIDESDE
NCT04819204·Not applicable·INTERVENTIONAL

Testosterone and Neurovascular Control in Humans

Status

Unknown

Phase

Not applicable

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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. Given that low testosterone levels are associated with an increased risk of cardiovascular disease, reduced exercise capacity and vascular dysfunction, it is evident that testosterone plays a pivotal role in autonomic and vascular function in men. Our 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. The outcomes of these studies will provide novel information regarding the role of male sex hormones in autonomic and vascular control, and further our understanding of the influence of sex hormones on human physiology.

Interventions

Treatment arms and agents.

DRUG

Cetrorelix Acetate

GnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily.

DRUG

Testosterone gel

Testosterone gel - transdermal application of 5mg/day on Day 7-14 of GnRH antagonist

Timeline

From registration to results.

  1. First posted

    Mar 26, 2021

  2. Study start

    Jun 2021

  3. Primary completion

    Dec 2023

  4. Study completion

    Dec 2023

  5. Results posted

    Not reported

  6. Registry updated

    Mar 26, 2021

Outcomes

What the study measures.

Primary outcomes

Muscle sympathetic nerve activity

Time frame · After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Multi-unit postganglionic muscle sympathetic nerve activity (MSNA) will be measured by inserting a unipolar tungsten microelectrode into the peroneal nerve near the fibular head of the leg. Neural signals will be amplified, filtered (bandwidth, 700-2,000 Hz), rectified, and integrated (time constant, 0.1 s) to obtain mean voltage neurograms. MSNA will be measured during both trials to evaluate the effect of testosterone on sympathetic activity directed toward the musculature.

Endothelial function

Time frame · After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Brachial artery flow-mediated dilation (FMD). Brachial artery FMD measures will be performed non-invasively via Doppler ultrasound.

Forearm blood flow

Time frame · After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Forearm blood flow will be measured using Doppler ultrasound at baseline and during stress (e.g. exercise)

Secondary outcomes

Skeletal muscle microvascular blood flow

Time frame · After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Microvascular blood flow will be measured using Diffuse correlation spectroscopy.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion Criteria: * Moderately active * Free of chronic disease Exclusion Criteria: * congenital or acquired hypogonadism * drug/alcohol dependence * hypertension * current smoker * current opioid or cannabis user * diabetes * inability to provide written consent * parkinson's disease * cardiovascular disease * testosterone use within the last year

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

the University of Western Ontario

London, Ontario, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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