Testosterone DeficiencyNCT03313635
Evaluation of Prealbumin Levels in Men With Low-T
An observational study of Testosterone Deficiency, run by Beckman Coulter, Inc. at 1 site in United States.
Trial summary
This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Testosterone Deficiency
- What is being tested?
- Men presenting with low-T
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 31 Dec 2017
- 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 40 to 75 years
- Men only
- Adult, Older adult
Study population: Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.
Who may be able to join
- Provide responses to standard questionnaires administered to subjects
- Written Informed Consent obtained
- Male sex at birth
- ≥ 40 and ≤ 75 years of age
- Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
- Able and willing to provide blood specimens and follow study schedule
- A final diagnosis can be established (androgen deficient versus not androgen deficient)
Who cannot join
- Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
- Use of opioid medication within 3 months prior to enrollment
- Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
- Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
- Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
- Diagnosis of prolactinoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Prealbumin (Transthyretin) Levels in Men With Low-T
This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.
- Conditions
- Testosterone Deficiency
- Being tested
- Men presenting with low-T
- Keywords
- Prealbumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Men presenting with low-TDiagnostic test
Evaluation of prealbumin levels.
| Study group | Role | What they receive |
|---|---|---|
| Men presenting with low-T | Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels. Receives: Diagnostic Test: Men presenting with low-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prealbumin Levels
Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start8 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testosterone 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Morgentaler, MD, Principal investigator, Men's Health Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313635
- Sponsor's protocol ID
- AND-1-17
- Status last verified
- Jul 2018
- First submitted
- 13 Oct 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prealbumin (Transthyretin) Levels in Men With Low-T
- ClinicalTrials.gov ID
- NCT03313635
- Acronym / sponsor ID
- AND-1-17
- Conditions
- Testosterone Deficiency
- Keywords
- Prealbumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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.
This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men presenting with low-T | – | Diagnostic Test: Men presenting with low-TMen presenting with low-t will undergo a blood draw for evaluation of prealbumin levels. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.
Key inclusion criteria (7 listed)
- Provide responses to standard questionnaires administered to subjects
- Written Informed Consent obtained
- Male sex at birth
- ≥ 40 and ≤ 75 years of age
- Presentation to the clinic with symptoms suggestive of low testosterone such as loss of libido, erectile dysfunction, cognitive or mood disturbances, etc.
Key exclusion criteria (6 listed)
- Previous exposure to exogenous T, DHEA, clomiphen citrate, or other Selective Estrogen Receptor Modulators, or OTC or herbals (Treatment Naïve)
- Use of opioid medication within 3 months prior to enrollment
- Serious psychiatric disease or uncontrolled medical illness, as suspected from medical history or clinical examination
- Use of any sex hormones or steroidal anabolic drug supplements (OTC or prescribed)(Treatment Naïve)
- Incapable of giving informed consent or complying with protocol or unwilling to comply with protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Men presenting with low-TEvaluation of prealbumin levels. | Diagnostic test | Men presenting with low-T |
Primary outcome
Prealbumin Levels
Time frame: 1 day
Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Abraham Morgentaler, MD principal investigator
Men's Health Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testosterone Deficiency, run by Beckman Coulter, Inc. at 1 site 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prealbumin Levels (time frame: 1 day). 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 13 Jul 2018.