HealthyEarly Phase 1T estersNCT06393634
Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration
A Early Phase 1 study testing Testosterone injection, Testosterone gel and Testosterone Oral in people with Healthy, run by Sports Medicine Research and Testing Laboratory at 1 site in United States.
Trial summary
Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Testosterone injection, Testosterone gel and Testosterone Oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 27 Nov 2024
- Phase
- Early Phase 1
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HEALTHY MALE ADULTS, AGED 18-60 YEARS
Who cannot join
- Individuals currently enrolled in a registered testing pool for anti-doping purposes
- Unwilling to provide urine or blood samples
- Individuals who are not actively exercising
- Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician
- Individuals that have an elevated baseline hematocrit as determined by the PI
- Individuals who are diabetic or are currently taking diabetic medications.
Show all 9Show fewer
- Individuals that have donated blood (approximately 500 mL) in the past 8 weeks
- Individuals with severe acne
- Individuals with a history of cancer, cardiac, renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports Medicine Research and Testing Laboratory
South Jordan, Utah, 84095
About this study
Official title: Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective
Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues
Read the detailed description
Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.
- Conditions
- Healthy
- Being tested
- Testosterone injection, Testosterone gel, Testosterone Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone injectionDrug
Also called testosterone cipionate, enanthate,or propionate
A single injection of testosterone
Testosterone gelDrug
Also called testosterone transdermal
A daily dose of testosterone gel
Testosterone OralDrug
Also called testosterone undecanoate
A twice-daily pill of testosterone pill to swallow
| Study group | Role | What they receive |
|---|---|---|
| Testosterone group one | Active comparator | The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. Receives: Drug: Testosterone injection; Drug: Testosterone gel |
| Testosterone group two | Active comparator | The participant will receive a single injection of one of three types of testosterone in phase one.
In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. Receives: Drug: Testosterone injection; Drug: Testosterone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection windows of testosterone administered via injection, oral and skin cream.
Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream
Measured: 12 weeks
Changes in serum concentration of testosterone
Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone
Measured: 12 weeks
Changes in serum concentration of androstenedione
Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone
Measured: 12 weeks
Changes in serum concentration of luteinizing hormone
Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone
Measured: 12 weeks
Secondary outcomes (1)
Direct detection of testosterone esters
Direct detection of testosterone esters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start27 Nov 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups in phase one and two groups in phase two, randomized by a computer.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sports Medicine Research and Testing Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoff Miller, PhD, Study director, Sports Medicine Research and Testing Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393634
- Sponsor's protocol ID
- SMRTL.2024.01
- Acronym
- T esters
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective
- ClinicalTrials.gov ID
- NCT06393634
- Acronym / sponsor ID
- T esters / SMRTL.2024.01
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sports Medicine Research and Testing LaboratoryIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 1 May 2024 (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.
Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues
Detailed description
Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three groups in phase one and two groups in phase two, randomized by a computer.
| Arm | Type | Receives |
|---|---|---|
| Testosterone group one | Active comparator | Drug: Testosterone injection, Drug: Testosterone gelThe participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. |
| Testosterone group two | Active comparator | Drug: Testosterone injection, Drug: Testosterone OralThe participant will receive a single injection of one of three types of testosterone in phase one. In phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HEALTHY MALE ADULTS, AGED 18-60 YEARS
Key exclusion criteria (9 listed)
- Individuals currently enrolled in a registered testing pool for anti-doping purposes
- Unwilling to provide urine or blood samples
- Individuals who are not actively exercising
- Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician
- Individuals that have an elevated baseline hematocrit as determined by the PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone injectionAlso: testosterone cipionate, enanthate,or propionateA single injection of testosterone | Drug | Testosterone group one, Testosterone group two |
| Testosterone gelAlso: testosterone transdermalA daily dose of testosterone gel | Drug | Testosterone group one |
| Testosterone OralAlso: testosterone undecanoateA twice-daily pill of testosterone pill to swallow | Drug | Testosterone group two |
Primary outcome
Detection windows of testosterone administered via injection, oral and skin cream.
Time frame: 12 weeks
Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream
Changes in serum concentration of testosterone
Time frame: 12 weeks
Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone
Changes in serum concentration of androstenedione
Time frame: 12 weeks
Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone
Changes in serum concentration of luteinizing hormone
Time frame: 12 weeks
Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone
1 secondary outcome
Direct detection of testosterone esters
Time frame: 12 weeks
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 3 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Geoff Miller, PhD study director
Sports Medicine Research and Testing Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Testosterone injection, Testosterone gel and Testosterone Oral in people with Healthy, run by Sports Medicine Research and Testing Laboratory 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 1 inclusion and 9 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 3 Dec 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Detection windows of testosterone administered via injection, oral and skin cream. (time frame: 12 weeks). The study lists 4 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 3 Dec 2024.