Evaluation of Prealbumin Levels in Men With Low-T

Completed

Conditions studied: Testosterone Deficiency

In brief

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.

Key facts

Study ID: NCT03313635
Run by: Beckman Coulter, Inc.
People needed: 19
Starts: 2017-09-08
Expected to finish: 2017-12-31
Last updated by the study team: 2018-07-13

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

Men's Health Boston — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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