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Completed

NCT Number: NCT03091296

Diurnal Testosterone Concentration

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.

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Key information

Age range

18 year–46 year

Sex eligibility

Male

Study type

Observational

Primary location

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Men's Health Boston

Other

Registry information

Official study title

Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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