Diurnal Testosterone Concentration

Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency

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.

Study Overview

• Status: Completed
• Conditions: Testosterone Deficiency

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

24 male subjects (12 with TD and 12 without TD)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of serum total testosterone concentration	Blood samples analyzed by Beckman assays and equipment	24 hours
Change in levels of serum calculated free testosterone concentration	Blood samples analyzed by Beckman assays and equipment	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in levels of estradiol	Blood samples analyzed by Beckman assays and equipment	24 hours
Change in levels of serum LH	Blood samples analyzed by Beckman assays and equipment	24 hours
Change in levels of serum FSH	Blood samples analyzed by Beckman assays and equipment	24 hours
Change in levels of serum SHBG	Blood samples analyzed by Beckman assays and equipment	24 hours
Change in levels of whole blood hematocrit	Blood samples analyzed by Quest assays and equipment	24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): January 2, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MHB022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No