Testosterone and Neurovascular Control in Humans

NCT04819204 | Unknown

• 1 other identifier: 117996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Muscle sympathetic nerve activity

  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.

  After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

• Endothelial function

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

  After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

• Forearm blood flow

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

  After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Secondary Outcomes (1)

• Skeletal muscle microvascular blood flow

  After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Other Outcomes (1)

• Sex hormones

  After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone

Study Arms (2)

GnRH antagonist alone

EXPERIMENTAL

Intervention: Cetrorelix acetate (Cetrotide)

Drug: Cetrorelix Acetate

GnRH antagonist + Testosterone add-back

EXPERIMENTAL

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

Drug: Cetrorelix Acetate; Drug: Testosterone gel

Interventions

Cetrorelix Acetate DRUG

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

Also known as: Cetrotide

GnRH antagonist + Testosterone add-back; GnRH antagonist alone

Testosterone gel DRUG

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

Also known as: Androgel 1%

GnRH antagonist + Testosterone add-back

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Moderately active
• Free of chronic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

the University of Western Ontario

London, Ontario, N6A 5B9, Canada

Location

MeSH Terms

Interventions

cetrorelix

Study Officials

• Joel K Shoemaker, Ph.D.

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew D'Souza, MSc

CONTACT

519-661-2111; adsouz58@uwo.ca

Arlene Fleischhauer, RN

CONTACT

afleisc@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)