Skip to main content
OpenTrials
Completed

NCT Number: NCT03313635

Evaluation of Prealbumin 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Testosterone Deficiency

Age range

40 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Men presenting with low-T

Diagnostic Test

Evaluation of prealbumin levels.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

Prealbumin (Transthyretin) Levels in Men With Low-T

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2017
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.