Evaluation of Prealbumin Levels in Men With Low-T

Testosterone Deficiency Clinical Trial

Official title:

Prealbumin (Transthyretin) Levels in Men With Low-T

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313635
• Other study ID #: AND-1-17
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Testosterone Deficiency

Intervention

Diagnostic Test:
• Men presenting with low-T
Evaluation of prealbumin levels.

Locations

Country	Name	City	State
United States	Men's Health Boston	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prealbumin Levels	Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)	1 day