Testosterone and Neurovascular Control in Humans

Western University, Canada

Status: Unknown

Conditions: Healthy

Treatments: Drug: Testosterone gel; Drug: Cetrorelix Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT04819204

117996

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

GnRH antagonist alone

Experimental group

Description:

Intervention: Cetrorelix acetate (Cetrotide)

Treatment:

Drug: Cetrorelix Acetate

GnRH antagonist + Testosterone add-back

Experimental group

Description:

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

Treatment:

Drug: Cetrorelix Acetate

Drug: Testosterone gel