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Diurnal Testosterone Concentration

Sponsor
Men's Health Boston (Other)
Overall Status
Completed
CT.gov ID
NCT03091296
Collaborator
(none)
24
Enrollment
1
Location
3.6
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this case-controlled, observational study, 24 subjects will participate in a 12-hour blood collection with a single blood draw at +24 hours. 12 men will have low testosterone levels (hypogonadism) and 12 men will have normal testosterone levels. Blood samples will be drawn every 2 hours and later analyzed for total testosterone and calculated free testosterone. The primary objective of this study is to assess the degree of diurnal variation in men with testosterone deficiency.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency
    Actual Study Start Date :
    Sep 13, 2017
    Actual Primary Completion Date :
    Oct 10, 2017
    Actual Study Completion Date :
    Jan 2, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Men with testosterone deficiency

    Screening testosterone concentration of less than 350 ng/dL
    Men without testosterone deficiency

    Screening testosterone concentration of greater than 350 ng/dL

    Outcome Measures

    Primary Outcome Measures

    1. Change in levels of serum total testosterone concentration [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    2. Change in levels of serum calculated free testosterone concentration [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    Secondary Outcome Measures

    1. Change in levels of estradiol [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    2. Change in levels of serum LH [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    3. Change in levels of serum FSH [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    4. Change in levels of serum SHBG [24 hours]

      Blood samples analyzed by Beckman assays and equipment

    5. Change in levels of whole blood hematocrit [24 hours]

      Blood samples analyzed by Quest assays and equipment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 46 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Men with testosterone deficiency:

    • Ability to read, write, and understand English

    • Male sex at birth

    • Age greater than or equal to 18

    • Age less than 46

    • Diagnosed with testosterone deficiency prior to visit 1

    • Screening testosterone concentration of less than 350 ng/dL

    • Willing and able to comply with the study protocol

    • Willing to provide informed consent for this study

    • No previous exposure to exogenous T unless off therapy for at least 4 weeks

    Men without testosterone deficiency:

    • Ability to read, write, and understand English

    • Male sex at birth

    • Age greater than or equal to 18

    • Age less than 46

    • Never diagnosed with testosterone deficiency

    • Screening testosterone concentration of greater than 350 ng/dL

    • Willing and able to comply with the study protocol

    • Willing to provide informed consent for this study

    • No previous exposure to exogenous T

    Exclusion Criteria:

    • Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 4 weeks

    • Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination

    • Used any sex hormones or steroidal anabolic drug supplements within 28 days before screening testosterone collection

    • Incapable of giving informed consent or complying with the protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Men's Health Boston Chestnut Hill Massachusetts United States 02467

    Sponsors and Collaborators

    • Men's Health Boston

    Investigators

    • Principal Investigator: Abraham Morgentaler, MD, Men's Health Boston, Harvard Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Abraham Morgentaler, Director, Men's Health Boston
    ClinicalTrials.gov Identifier:
    NCT03091296
    Other Study ID Numbers:
    • MHB022
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Mar 27, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 27, 2018