Clinical trial NCT03091296: Diurnal Testosterone Concentration
Official title: Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testosterone Deficiency
Lead sponsor: Men's Health Boston
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 24 male subjects (12 with TD and 12 without TD)

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.


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

Primary outcomes:
measure: Change in levels of serum total testosterone concentration
timeFrame: 24 hours
measure: Change in levels of serum calculated free testosterone concentration
timeFrame: 24 hours
Secondary outcomes:
measure: Change in levels of estradiol
timeFrame: 24 hours
measure: Change in levels of serum LH
timeFrame: 24 hours
measure: Change in levels of serum FSH
timeFrame: 24 hours
measure: Change in levels of serum SHBG
timeFrame: 24 hours
measure: Change in levels of whole blood hematocrit
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Men's Health Boston
state: Massachusetts
Study officials:
affiliation: Men's Health Boston, Harvard Medical School
name: Abraham Morgentaler, MD
role: PRINCIPAL_INVESTIGATOR
References: