Diurnal Testosterone Concentration

NCT03091296 | Completed

• 1 other identifier: MHB022
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Testosterone Deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in levels of estradiol

  24 hours

• Change in levels of serum LH

  24 hours

• Change in levels of serum FSH

  24 hours

• Change in levels of serum SHBG

  24 hours

• Change in levels of whole blood hematocrit

  24 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Men's Health Boston: lead

Study Sites (1)

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

Study Officials

• Abraham Morgentaler, MD

  Men's Health Boston, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: September 13, 2017
• Primary Completion: October 10, 2017
• Study Completion: January 2, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (1)