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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01909505

Enrollment

Registered

2013-07-26

Start date

2013-06-30

Completion date

2014-07-31

Last updated

2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Known Androgen Deficiency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
blood and saliva testosterone	1 year	Measures of blood and saliva testosterone

Countries

United States

Contacts

Primary ContactWest T Moore, M.D.

mooret@jhmi.edu410 967 7395

Outcome results