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Diurnal Testosterone Concentration

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ClinicalTrials.gov Identifier: NCT03091296
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston

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
Testosterone Deficiency

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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 : September 13, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Change in levels of serum total testosterone concentration [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment

  2. Change in levels of serum calculated free testosterone concentration [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment


Secondary Outcome Measures :
  1. Change in levels of estradiol [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment

  2. Change in levels of serum LH [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment

  3. Change in levels of serum FSH [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment

  4. Change in levels of serum SHBG [ Time Frame: 24 hours ]
    Blood samples analyzed by Beckman assays and equipment

  5. Change in levels of whole blood hematocrit [ Time Frame: 24 hours ]
    Blood samples analyzed by Quest assays and equipment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
24 male subjects (12 with TD and 12 without TD)
Criteria

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

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): NCT03091296


Locations
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United States, Massachusetts
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Men's Health Boston
Investigators
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Principal Investigator: Abraham Morgentaler, MD Men's Health Boston, Harvard Medical School

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Responsible Party: Dr. Abraham Morgentaler, Director, Men's Health Boston
ClinicalTrials.gov Identifier: NCT03091296     History of Changes
Other Study ID Numbers: MHB022
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents