Testosterone and Neurovascular Control in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GnRH antagonist alone

Intervention: Cetrorelix acetate (Cetrotide)

Group Type EXPERIMENTAL

Cetrorelix Acetate

Intervention Type DRUG

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

GnRH antagonist + Testosterone add-back

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

Group Type EXPERIMENTAL

Cetrorelix Acetate

Intervention Type DRUG

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

Testosterone gel

Intervention Type DRUG

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

Interventions

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Cetrorelix Acetate

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

Intervention Type DRUG

Testosterone gel

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

Intervention Type DRUG

Other Intervention Names

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Cetrotide Androgel 1%

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes