Evaluation of Prealbumin Levels in Men With Low-T

NCT03313635 | Completed FDA Device

• 1 other identifier: AND-1-17
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Testosterone Deficiency

Keywords

Prealbumin

Outcome Measures

Primary Outcomes (1)

• Prealbumin Levels

  Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)

  1 day

Study Arms (1)

Men presenting with low-T

Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels.

Diagnostic Test: Men presenting with low-T

Interventions

Men presenting with low-T DIAGNOSTIC_TEST

Evaluation of prealbumin levels.

Men presenting with low-T

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Male sex at birth
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (1)

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen serum samples are retained for this study and possible future studies.

Study Officials

• Abraham Morgentaler, MD

  Men's Health Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: September 8, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)