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Trial record 2 of 365 for:    transthyretin

Evaluation of Prealbumin Levels in Men With Low-T

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ClinicalTrials.gov Identifier: NCT03313635
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Testosterone Deficiency Diagnostic Test: Men presenting with low-T

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prealbumin (Transthyretin) Levels in Men With Low-T
Actual Study Start Date : September 8, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
Men presenting with low-T
Men presenting with low-t will undergo a blood draw for evaluation of prealbumin levels.
Diagnostic Test: Men presenting with low-T
Evaluation of prealbumin levels.




Primary Outcome Measures :
  1. Prealbumin Levels [ Time Frame: 1 day ]
    Evaluation of prealbumin levels in subjects presenting for evaluation of possible late onset adult hypogonadism diagnosed with and without Androgen Deficiency (AD)


Biospecimen Retention:   Samples Without DNA
Frozen serum samples are retained for this study and possible future studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male sex at birth
Sampling Method:   Non-Probability Sample
Study Population
Men between the ages of 40 and 75 presenting with signs/symptoms of low-T.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313635


Locations
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United States, Massachusetts
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Beckman Coulter, Inc.
Investigators
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Principal Investigator: Abraham Morgentaler, MD Men's Health Boston

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Responsible Party: Beckman Coulter, Inc.
ClinicalTrials.gov Identifier: NCT03313635     History of Changes
Other Study ID Numbers: AND-1-17
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Beckman Coulter, Inc.:
Prealbumin