Status:
COMPLETED
Evaluation of Prealbumin Levels in Men With Low-T
Lead Sponsor:
Beckman Coulter, Inc.
Conditions:
Testosterone Deficiency
Eligibility:
MALE
40-75 years
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03313635
Start Date
September 8 2017
End Date
December 31 2017
Last Update
July 13 2018
Active Locations (1)
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1
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467