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Hormone Therapy
Testosterone Therapy for Low Testosterone (CardioVOLT Trial)
N/A
Waitlist Available
Led By Kerrie Moreau, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 28 days
Summary
This trial plans to study how heart and vascular health decline in older men, specifically if it's due to damage to mitochondria.
Who is the study for?
Men aged 18-40 and 50-75 with low testosterone levels (<300 ng/dl) or normal (400-1000 ng/dl), healthy as per medical exams, non-smokers, not on sex hormones for a year, no vitamin supplements or anti-inflammatory meds (or willing to stop), BMI <40 kg/m2, sedentary or lightly active. Excludes those with certain diseases like heart disease, diabetes, cancer; abnormal ECGs; infections; epilepsy; allergies to trial drugs.
What is being tested?
The study is testing the effects of lowering testosterone levels using Arimidex and Acyline versus placebo treatments on cardiovascular health in older men. It aims to understand how reduced testosterone affects heart health by examining mitochondria function.
What are the potential side effects?
Potential side effects may include reactions at the gel application site, hormonal imbalances leading to mood changes or fatigue, possible impact on bone density due to hormone alteration from Arimidex and Acyline.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Arterial stiffness
Carotid artery compliance
Endothelial function
+1 moreSecondary study objectives
COX IV
Mitochondrial RCR
MnSOD
+3 moreOther study objectives
Body Composition
Endothelin-1 (ET-1)
Glucose Concentrations
+4 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Group 2: Acyline plusTestosteroneActive Control3 Interventions
Acyline plus transdermal testosterone gel plus placebo tablet.
Group II: Group 3: Acyline plus Testosterone plus Arimidex)Active Control3 Interventions
Acyline plus transdermal testosterone gel plus Aromatase inhibitor (Arimidex) oral.
Group III: Group 1: Acyline plus placebo (No Testosterone Add-Back)Placebo Group3 Interventions
Acyline plus placebo gel and placebo tablet.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,800 Previous Clinical Trials
2,821,700 Total Patients Enrolled
3 Trials studying Hypogonadism
143 Patients Enrolled for Hypogonadism
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,183,861 Total Patients Enrolled
4 Trials studying Hypogonadism
342 Patients Enrolled for Hypogonadism
Kerrie Moreau, PhDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
240 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity is not normal when you are at rest.Men between 18-40 years old and 50-75 years old.You cannot take certain hormones or medications like mannitol, GnRH, or its analogs.You have had or currently have prostate or breast cancer, or other types of cancer that depend on sex hormones to grow.You have a condition that affects your nerves.You have had a stomach ulcer or bleeding in the past.You currently have an infection.Your blood pressure when you are not active should be less than 160/90 mmHg.You have a history of epilepsy or other seizure disorder.The group with low testosterone has levels below 300 ng/dl, while the group with normal testosterone has levels between 400-1000 ng/dl.You have a condition that makes it unsafe for you to take a medication called a Gonadotropin releasing hormone (GnRH) antagonist.You are allergic to Acyline, Androgel®, or Arimidex®, which are medications used in the study.You have a heart, kidney, or liver condition that is already present or currently active.You have diabetes.Your body mass index is less than 40.People who do not smoke.Your blood sugar when you haven't eaten should be less than 126 milligrams per deciliter.You do not regularly engage in intense physical activity, like running or playing sports, at least three days a week.You are not taking certain medications that could affect your heart or blood vessels, like blood pressure or cholesterol drugs, or corticosteroids.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Acyline plus placebo (No Testosterone Add-Back)
- Group 2: Group 2: Acyline plusTestosterone
- Group 3: Group 3: Acyline plus Testosterone plus Arimidex)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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