HealthyNCT04819204
Testosterone and Neurovascular Control in Humans
A study testing Cetrorelix Acetate and Testosterone gel in people with Healthy, run by Western University, Canada at 1 site in Canada.
Trial summary
The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cetrorelix Acetate and Testosterone gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Moderately active
- Free of chronic disease
Who cannot join
- congenital or acquired hypogonadism
- drug/alcohol dependence
- hypertension
- current smoker
- current opioid or cannabis user
- diabetes
Show all 10Show fewer
- inability to provide written consent
- parkinson's disease
- cardiovascular disease
- testosterone use within the last year
Trial locations and contacts
1 site in 1 country.
Arlene Fleischhauer, RN contact
About this study
Official title: Exploring the Role of Testosterone on Neurovascular Control in Humans
The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.
Read the 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.
- Conditions
- Healthy
- Being tested
- Cetrorelix Acetate, Testosterone gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix AcetateDrug
Also called Cetrotide
GnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily.
Testosterone gelDrug
Also called Androgel 1%
Testosterone gel - transdermal application of 5mg/day on Day 7-14 of GnRH antagonist
| Study group | Role | What they receive |
|---|---|---|
| GnRH antagonist alone | Experimental | Intervention: Cetrorelix acetate (Cetrotide) Receives: Drug: Cetrorelix Acetate |
| GnRH antagonist + Testosterone add-back | Experimental | Intervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel) Receives: Drug: Cetrorelix Acetate; Drug: Testosterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Secondary outcomes (1)
Skeletal muscle microvascular blood flow
Microvascular blood flow will be measured using Diffuse correlation spectroscopy.
Measured: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Shoemaker, Western University, Canada
- Investigators
- Joel K Shoemaker, Ph.D., Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819204
- Sponsor's protocol ID
- 117996
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Testosterone on Neurovascular Control in Humans
- ClinicalTrials.gov ID
- NCT04819204
- Acronym / sponsor ID
- 117996
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of these studies are to evaluate the role of testosterone on autonomic and vascular function in men.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH antagonist alone | Experimental | Drug: Cetrorelix AcetateIntervention: Cetrorelix acetate (Cetrotide) |
| GnRH antagonist + Testosterone add-back | Experimental | Drug: Cetrorelix Acetate, Drug: Testosterone gelIntervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Moderately active
- Free of chronic disease
Key exclusion criteria (10 listed)
- congenital or acquired hypogonadism
- drug/alcohol dependence
- hypertension
- current smoker
- current opioid or cannabis user
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetrorelix AcetateAlso: CetrotideGnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily. | Drug | GnRH antagonist + Testosterone add-back, GnRH antagonist alone |
| Testosterone gelAlso: Androgel 1%Testosterone gel - transdermal application of 5mg/day on Day 7-14 of GnRH antagonist | Drug | GnRH antagonist + Testosterone add-back |
Primary outcome
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)
1 secondary outcome
Skeletal muscle microvascular blood flow
Time frame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Fleischhauer, RN contact
Joel K Shoemaker, Ph.D. principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetrorelix Acetate and Testosterone gel in people with Healthy, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew D'Souza, MSc (519-661-2111 ext. 88084, adsouz58@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sympathetic nerve activity (time frame: After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.