DRUG
Cetrorelix Acetate
GnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily.
Status
Unknown
Phase
Not applicable
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.
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
DRUG
GnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily.
DRUG
Testosterone gel - transdermal application of 5mg/day on Day 7-14 of GnRH antagonist
Timeline
First posted
Mar 26, 2021
Study start
Jun 2021
Primary completion
Dec 2023
Study completion
Dec 2023
Results posted
Not reported
Registry updated
Mar 26, 2021
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)
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
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
Canada. Showing up to 24 locations stored in the fast local snapshot.
the University of Western Ontario
London, Ontario, Canada
Publications
No PMID-linked publications were present in this registry snapshot.
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