Diurnal Testosterone Concentration

Completed

• Conditions: Testosterone Deficiency

• Registration Number: NCT03091296
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-09-13
• Primary Completion: 2017-10-10
• Study Completion: 2018-01-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in levels of serum total testosterone concentration	24 hours	Blood samples analyzed by Beckman assays and equipment
Change in levels of serum calculated free testosterone concentration	24 hours	Blood samples analyzed by Beckman assays and equipment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Men's Health Boston; 🇺🇸 Chestnut Hill, Massachusetts, United States