MedTrace Logo

Cardiovascular Outcomes of Low Testosterone

NCT02758431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-10-10

No results posted yet for this study

Summary

This study plans to learn more about heart and vascular aging in men. In some men as they get older, testosterone levels fall below the normal range for young men. Also, as men get older cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men. Also we want to find out what happens when testosterone levels are lowered for a short time. Specifically, we want to see if the reduction in cardiovascular health in older men with low testosterone levels is because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand why cardiovascular health declines in older men with low testosterone levels compared to younger men and older men who have higher testosterone levels. Knowing this information will help to develop therapies to prevent heart disease in men.

Conditions

  • Hypogonadism

Interventions

DRUG

Acyline

Acyline 300ug/kg injection will be administered on Day 0 and on day 14

DRUG

Placebo Gel

Placebo gel packet applied daily for 28 days.

DRUG

Placebo Tablet

Placebo oral tablet taken daily for 28 days.

DRUG

Testosterone Gel

Testosterone Gel applied daily for 28 days

DRUG

Arimidex

Arimidex Oral Tablet 1mg taken orally daily for 28 days

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kerrie Moreau, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2023-01-04
Completion
2023-01-04

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758431 on ClinicalTrials.gov