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CompletedNCT03313635Updated Jul 13, 2018

Evaluation of Prealbumin Levels in Men With Low-T

An observational study in Testosterone Deficiency, sponsored by Beckman Coulter, Inc.. Completed at 1 site in United States. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Beckman Coulter, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
40 Years to 75 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Testosterone Deficiency

Keywords

  • Prealbumin
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testMen presenting with low-T

    Evaluation of prealbumin levels.

05

What researchers measure

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)

    Time frame: 1 day

06

Study locations

1 site
  • Men's Health Boston
    Chestnut Hill, Massachusetts 02467, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03313635
Lead sponsor
Beckman Coulter, Inc.
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Sep 8, 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Jul 13, 2018

Study contacts

Abraham Morgentaler, MD
principal investigator · Men's Health Boston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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