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

Saliva Biomarkers

Status

Unknown

Conditions

Known Androgen Deficiency

Study type

Observational

Funder types

Industry

Identifiers

NCT01909505

Saliva Testosterone

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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