Testosterone Deficiency
Conditions
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.
Interventions
None listed
Sponsors
Men's Health Boston
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 46 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 whole blood hematocrit | 24 hours | Blood samples analyzed by Quest assays and equipment |
| Change in levels of serum SHBG | 24 hours | Blood samples analyzed by Beckman assays and equipment |
| Change in levels of estradiol | 24 hours | Blood samples analyzed by Beckman assays and equipment |
Countries
United States
Outcome results
None listed