Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men

July 24, 2013 updated by: Saliva Biomarkers, Inc.

Comparison of Salivary Testosterone With Serum Free Testosterone Done by Equilibrium Dialysis.

Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling. Study participants will be asked to provide samples of blood and saliva for the measurement of testosterone. These results may lead to the development of a saliva test for testosterone.

Study Overview

Status

Unknown

Conditions

Detailed Description

Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Contact:
        • Principal Investigator:
          • West T Moore, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21827
        • Recruiting
        • John's Hopkins University Medical Center
        • Contact:
        • Principal Investigator:
          • Adrian Dobbs, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Forty normal males and 20 male subjects, 25 to 65 years of age.

Description

Inclusion Criteria:

  • Normal male subjects aged 20-65 years

Exclusion Criteria:

  • Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Normal Males
Males with normal levels of serum testosterone
Hypogonadal males
Males known to have low levels of serum testosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood and saliva testosterone
Time Frame: 1 year
Measures of blood and saliva testosterone
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saliva Biomarkers, Inc.

Investigators

  • Principal Investigator: West T Moore, M.D., Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Saliva Testosterone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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