Evaluation of Prealbumin Levels in Men With Low-T

Completed

• Conditions: Testosterone Deficiency
• Interventions: Diagnostic Test: Men presenting with low-T

• Registration Number: NCT03313635
• Lead Sponsor: Beckman Coulter, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-08
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prealbumin Levels	1 day	Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)

Trial Locations

Locations (1)

Men's Health Boston; 🇺🇸 Chestnut Hill, Massachusetts, United States