Healthy VolunteersPhase 1TSTNCT04207684
Generation of Biological Samples Positive to Testosterone for Anti-doping Control
A Phase 1 study testing Testosterone injection in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Background: Testosterone is a steroid widely known to improve physical performance due to its protein-anabolic effect. Like other androgenic anabolic steroids (EAA), testosterone is included on the World Anti-Doping Agency (WADA) list of prohibited substances. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Testosterone injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2020to 26 Feb 2020
- Phase
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers aged between 18 and 50 years.
- Able to understand and accept the trial procedures and able to sign an informed consent.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed before the test within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
- Body mass index (weight/height^2) between 19 and 25 kg/m2 and weight between 50 and 90 kg. BMI between 25 and 27 kg/m2 may be included according to Principal Investigator's criteria.
Who cannot join
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or similar nonapeptides, or to any of the excipients.
- Patient with history or current presence of breast cancer, liver cancer, or suspicion or confirmation of prostate carcinoma.
- History or current presence of prostate syndrome symptoms: frequent urination (both day and night), difficulty in starting urination, weak or discontinuous urinary stream, feeling of incomplete bladder emptying, or benign prostatic hyperplasia diagnosis.
- Levels of prostate specific antigen (PSA) > 4 ng/mL.
- Hematocrit value >50%.
- Patients with acute abdominal pain of unknown origin.
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- Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.
- Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
- Having participated in another clinical trial with medication in the three months prior to the start of the study.
- Having suffered some organic disease or major surgery in the six months prior to the start of the study.
- Clinical background or evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially history of venous thrombosis or thromboembolic disorders, thrombophilic alteration, edema, hypercalcemia, polycythemia, nephrosis, liver disease with altered liver function tests and porphyria.
- Having taken medication regularly in the month prior to the study sessions. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
- Smokers of more than 20 cigarettes a day in the 3 months before the study.
- Consumption of more than 40 g of alcohol daily.
- Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
- Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
- Positive serology for hepatitis B, C or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Testosterone is a steroid widely known to improve physical performance due to its protein-anabolic effect. Like other androgenic anabolic steroids (EAA), testosterone is included on the World Anti-Doping Agency (WADA) list of prohibited substances.
Read more
EAA are the most detected banned substances in anti-doping controls. Therefore, different analytical strategies are required to improve its detection.
Hypothesis:
The intramuscular administration of 250 mg of testosterone (cypionate) in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control.
Objectives:
Primary objective: To measure the concentrations of testosterone in urine for anti-doping control samples.
Secondary objective: To identify metabolites and precursors of testosterone in urine. To assess safety and tolerability of the drug used.
Methods:
Phase I, open, non-randomized clinical trial, with a treatment condition (testosterone) administered via intramuscular injection to 4 subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Testosterone injection
- Keywords
- Testosterone, Anti-doping control, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone injectionDrug
Also called Testex Prolongatum® 250 mg/2 mL
250 mg of testosterone cypionate (equivalent to 174,8 mg of testosterone) administered via intramuscular injection in a single dose (2 mL)
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Subjects receive a single-dose treatment. Urine samples will be collected until 5 days after administration (6 fractions: 0-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h post-administration). Receives: Drug: Testosterone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of testosterone
Concentration of testosterone in fraction-1 urine samples
Measured: 0-12 hours post-administration (Day 1)
Urine concentration of testosterone
Concentration of testosterone in fraction-2 urine samples
Measured: 12-24 hours post-administration (Day 1)
Urine concentration of testosterone
Concentration of testosterone in fraction-3 urine samples
Measured: 24-48 hours post-administration (Day 2)
Urine concentration of testosterone
Concentration of testosterone in fraction-4 urine samples
Measured: 48-72 hours post-administration (Day 3)
Urine concentration of testosterone
Concentration of testosterone in fraction-5 urine samples
Measured: 72-96 hours post-administration (Day 4)
Urine concentration of testosterone
Concentration of testosterone in fraction-6 urine samples
Measured: 96-120 hours post-administration (Day 5)
Secondary outcomes (6)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-1 urine samples
Measured: 0-12 hours post-administration (Day 1)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-2 urine samples
Measured: 12-24 hours post-administration (Day 1)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-3 urine samples
Measured: 24-48 hours post-administration (Day 2)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-4 urine samples
Measured: 48-72 hours post-administration (Day 3)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-5 urine samples
Measured: 72-96 hours post-administration (Day 4)
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in fraction-6 urine samples
Measured: 96-120 hours post-administration (Day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start4 Feb 2020
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M. Aldea Perona, Dr, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207684
- Sponsor's protocol ID
- IMIMFTCL/TST
- Acronym
- TST
- Status last verified
- Jul 2020
- First submitted
- 19 Dec 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Biological Samples Positive to Testosterone for Anti-doping Control
- ClinicalTrials.gov ID
- NCT04207684
- Acronym / sponsor ID
- TST / IMIMFTCL/TST
- Conditions
- Healthy Volunteers
- Keywords
- Testosterone, Anti-doping control, Athletic performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 23 Dec 2019 (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.
Background:
Testosterone is a steroid widely known to improve physical performance due to its protein-anabolic effect. Like other androgenic anabolic steroids (EAA), testosterone is included on the World Anti-Doping Agency (WADA) list of prohibited substances.
EAA are the most detected banned substances in anti-doping controls. Therefore, different analytical strategies are required to improve its detection.
Hypothesis:
The intramuscular administration of 250 mg of testosterone (cypionate) in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control.
Objectives:
Primary objective: To measure the concentrations of testosterone in urine for anti-doping control samples.
Secondary objective: To identify metabolites and precursors of testosterone in urine. To assess safety and tolerability of the drug used.
Methods:
Phase I, open, non-randomized clinical trial, with a treatment condition (testosterone) administered via intramuscular injection to 4 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: Testosterone injectionSubjects receive a single-dose treatment. Urine samples will be collected until 5 days after administration (6 fractions: 0-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h post-administration). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers aged between 18 and 50 years.
- Able to understand and accept the trial procedures and able to sign an informed consent.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed before the test within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
- Body mass index (weight/height^2) between 19 and 25 kg/m2 and weight between 50 and 90 kg. BMI between 25 and 27 kg/m2 may be included according to Principal Investigator's criteria.
Key exclusion criteria (17 listed)
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or similar nonapeptides, or to any of the excipients.
- Patient with history or current presence of breast cancer, liver cancer, or suspicion or confirmation of prostate carcinoma.
- History or current presence of prostate syndrome symptoms: frequent urination (both day and night), difficulty in starting urination, weak or discontinuous urinary stream, feeling of incomplete bladder emptying, or benign prostatic hyperplasia diagnosis.
- Levels of prostate specific antigen (PSA) > 4 ng/mL.
- Hematocrit value >50%.
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: Testex Prolongatum® 250 mg/2 mL250 mg of testosterone cypionate (equivalent to 174,8 mg of testosterone) administered via intramuscular injection in a single dose (2 mL) | Drug | Testosterone |
Primary outcome
Urine concentration of testosterone
Time frame: 0-12 hours post-administration (Day 1)
Concentration of testosterone in fraction-1 urine samples
Urine concentration of testosterone
Time frame: 12-24 hours post-administration (Day 1)
Concentration of testosterone in fraction-2 urine samples
Urine concentration of testosterone
Time frame: 24-48 hours post-administration (Day 2)
Concentration of testosterone in fraction-3 urine samples
Urine concentration of testosterone
Time frame: 48-72 hours post-administration (Day 3)
Concentration of testosterone in fraction-4 urine samples
Urine concentration of testosterone
Time frame: 72-96 hours post-administration (Day 4)
Concentration of testosterone in fraction-5 urine samples
Urine concentration of testosterone
Time frame: 96-120 hours post-administration (Day 5)
Concentration of testosterone in fraction-6 urine samples
6 secondary outcomes
Urine concentration of testosterone metabolites
Time frame: 0-12 hours post-administration (Day 1)
Urine concentration of testosterone metabolites
Time frame: 12-24 hours post-administration (Day 1)
Urine concentration of testosterone metabolites
Time frame: 24-48 hours post-administration (Day 2)
Urine concentration of testosterone metabolites
Time frame: 48-72 hours post-administration (Day 3)
Urine concentration of testosterone metabolites
Time frame: 72-96 hours post-administration (Day 4)
Urine concentration of testosterone metabolites
Time frame: 96-120 hours post-administration (Day 5)
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 17 Jul 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Ana M. Aldea Perona, Dr principal investigator
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone injection in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
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 5 inclusion and 17 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 17 Jul 2020. 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 Spain. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Urine concentration of testosterone (time frame: 0-12 hours post-administration (Day 1)). The study lists 6 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 17 Jul 2020.