Diurnal Testosterone Concentration

NCT ID: NCT03091296

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2018-01-02

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Men with testosterone deficiency

Screening testosterone concentration of less than 350 ng/dL

No interventions assigned to this group

Men without testosterone deficiency

Screening testosterone concentration of greater than 350 ng/dL

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Men's Health Boston

OTHER

Sponsor Role: lead

Responsible Party

Dr. Abraham Morgentaler

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abraham Morgentaler, MD

Role: PRINCIPAL_INVESTIGATOR

Men's Health Boston, Harvard Medical School

Locations

Men's Health Boston

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

MHB022

Identifier Type: -

Identifier Source: org_study_id