Known Androgen DeficiencyNCT01909505
Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men
An observational study of Known Androgen Deficiency, run by Saliva Biomarkers, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Known Androgen Deficiency
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Forty normal males and 20 male subjects, 25 to 65 years of age.
Who may be able to join
- Normal male subjects aged 20-65 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
John's Hopkins University Medical Center
Baltimore, Maryland, 21827
Ernest Evans, 410-955-2812, eevans21@jhmi.edu
Adrian Dobbs, M.D.
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Amber Surian, 202-444-1210, aas64@georgetown.edu
West T Moore, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Known Androgen Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Males | Males with normal levels of serum testosterone | |
| Hypogonadal males | Males known to have low levels of serum testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood and saliva testosterone
Measures of blood and saliva testosterone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Known Androgen DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saliva Biomarkers, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- West T Moore, M.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909505
- Sponsor's protocol ID
- Saliva Testosterone
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Salivary Testosterone With Serum Free Testosterone Done by Equilibrium Dialysis.
- ClinicalTrials.gov ID
- NCT01909505
- Acronym / sponsor ID
- Saliva Testosterone
- Conditions
- Known Androgen Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saliva Biomarkers, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Males | – | –Males with normal levels of serum testosterone |
| Hypogonadal males | – | –Males known to have low levels of serum testosterone |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Forty normal males and 20 male subjects, 25 to 65 years of age.
Key inclusion criteria (1 listed)
- Normal male subjects aged 20-65 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood and saliva testosterone
Time frame: 1 year
Measures of blood and saliva testosterone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
West T Moore, M.D. principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Known Androgen Deficiency, run by Saliva Biomarkers, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact West T Moore, M.D. (410 967 7395, mooret@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood and saliva testosterone (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.