Evaluation of Prealbumin Levels in Men With Low-T (NCT03313635) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Prealbumin Levels in Men With Low-T
United States19 participantsStarted 2017-09-08
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexMALE
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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