Diurnal Testosterone Concentration

Testosterone Deficiency Clinical Trial

Official title:

Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091296
• Other study ID #: MHB022
• Status: Completed
• First received: March 16, 2017
• Last updated: March 26, 2018
• Start date: September 13, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: March 2018
• Source: Men's Health Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2, 2018
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Testosterone Deficiency

Locations

Country	Name	City	State
United States	Men's Health Boston	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Men's Health Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of serum total testosterone concentration	Blood samples analyzed by Beckman assays and equipment	24 hours
Primary	Change in levels of serum calculated free testosterone concentration	Blood samples analyzed by Beckman assays and equipment	24 hours
Secondary	Change in levels of estradiol	Blood samples analyzed by Beckman assays and equipment	24 hours
Secondary	Change in levels of serum LH	Blood samples analyzed by Beckman assays and equipment	24 hours
Secondary	Change in levels of serum FSH	Blood samples analyzed by Beckman assays and equipment	24 hours
Secondary	Change in levels of serum SHBG	Blood samples analyzed by Beckman assays and equipment	24 hours
Secondary	Change in levels of whole blood hematocrit	Blood samples analyzed by Quest assays and equipment	24 hours