Testosterone DeficiencyNCT03091296
Diurnal Testosterone Concentration
An observational study of Testosterone Deficiency, run by Men's Health Boston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testosterone Deficiency
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 2 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 24 male subjects (12 with TD and 12 without TD)
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men with testosterone deficiency | Screening testosterone concentration of less than 350 ng/dL | |
| Men without testosterone deficiency | Screening testosterone concentration of greater than 350 ng/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of serum total testosterone concentration
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Change in levels of serum calculated free testosterone concentration
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Secondary outcomes (5)
Change in levels of estradiol
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Change in levels of serum LH
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Change in levels of serum FSH
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Change in levels of serum SHBG
Blood samples analyzed by Beckman assays and equipment
Measured: 24 hours
Change in levels of whole blood hematocrit
Blood samples analyzed by Quest assays and equipment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start13 Sep 2017
- Primary completion10 Oct 2017
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testosterone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Men's Health Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abraham Morgentaler, Men's Health Boston
- Investigators
- Abraham Morgentaler, MD, Principal investigator, Men's Health Boston, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091296
- Sponsor's protocol ID
- MHB022
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Testosterone Concentrations in Men With and Without Testosterone Deficiency
- ClinicalTrials.gov ID
- NCT03091296
- Acronym / sponsor ID
- MHB022
- Conditions
- Testosterone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Men's Health BostonUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men with testosterone deficiency | – | –Screening testosterone concentration of less than 350 ng/dL |
| Men without testosterone deficiency | – | –Screening testosterone concentration of greater than 350 ng/dL |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 24 male subjects (12 with TD and 12 without TD)
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in levels of serum total testosterone concentration
Time frame: 24 hours
Blood samples analyzed by Beckman assays and equipment
Change in levels of serum calculated free testosterone concentration
Time frame: 24 hours
Blood samples analyzed by Beckman assays and equipment
5 secondary outcomes
Change in levels of estradiol
Time frame: 24 hours
Change in levels of serum LH
Time frame: 24 hours
Change in levels of serum FSH
Time frame: 24 hours
Change in levels of serum SHBG
Time frame: 24 hours
Change in levels of whole blood hematocrit
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
Related trials for Testosterone Deficiency
Not yet recruiting
Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause
Menopause, Sexual Dysfunction
Enrolling by invitation
AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism
Hypogonadism, Male, Secondary Hypogonadism
RecruitingPhase 2
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Metastatic Prostate Cancer
RecruitingObservational study
Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Testosterone Deficiency, Male Hypogonadism
Active, not recruitingPhase 2
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Hypogonadism, Male, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Morgentaler, MD principal investigator
Men's Health Boston, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testosterone Deficiency, run by Men's Health Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of serum total testosterone concentration (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.