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

• Conditions: Known Androgen Deficiency

• Registration Number: NCT01909505
• Lead Sponsor: Saliva Biomarkers, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Last Update Submitted: 2013-07-24
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood and saliva testosterone	1 year	Measures of blood and saliva testosterone

Trial Locations

Locations (2)

John's Hopkins University Medical Center; 🇺🇸 Baltimore, Maryland, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States