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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
Men aged 18-40 years and 50-75 years
Body mass index <40 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 28 days
Awards & highlights

CardioVOLT Trial 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.Check my eligibility
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.See study design
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.

CardioVOLT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Men between 18-40 years old and 50-75 years old.
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Your body mass index is less than 40.
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People who do not smoke.
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You do not regularly engage in intense physical activity, like running or playing sports, at least three days a week.
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You are not taking certain medications that could affect your heart or blood vessels, like blood pressure or cholesterol drugs, or corticosteroids.

CardioVOLT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arterial stiffness
Carotid artery compliance
Endothelial function
+1 more
Secondary outcome measures
COX IV
Mitochondrial RCR
MnSOD
+3 more
Other outcome measures
Body Composition
Endothelin-1 (ET-1)
Glucose Concentrations
+4 more

CardioVOLT Trial 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
1,709 Previous Clinical Trials
1,929,140 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,637 Previous Clinical Trials
28,001,324 Total Patients Enrolled
Kerrie Moreau, PhDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Testosterone Gel (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02758431 — N/A
Low Testosterone Research Study Groups: Group 1: Acyline plus placebo (No Testosterone Add-Back), Group 2: Acyline plusTestosterone, Group 3: Acyline plus Testosterone plus Arimidex)
Low Testosterone Clinical Trial 2023: Testosterone Gel Highlights & Side Effects. Trial Name: NCT02758431 — N/A
Testosterone Gel (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02758431 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~44 spots leftby Feb 2025