Anti-doping Campaign, Detection of HydrocortisonePhase 4H-CORTNCT04137302
Administration of Hydrocortisone in Young Healthy Male Volunteers
A Phase 4 study testing Hydrocortisone administration in people with Anti-doping Campaign, Detection of Hydrocortisone, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anti-doping Campaign, Detection of Hydrocortisone
- What is being tested?
- Hydrocortisone administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2019to 31 Jan 2020
- Phase
- Phase 4
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male subjects
- aged 18 to 30 years
- 18 < BMI < 28
- participating in regular physical activity (3-5 times/week)
- subjects not on medication
Who cannot join
- asthmatic subjects or history of respiratory or cardiac pathology; use of corticosteroids in the past 6 months; high blood pressure; ulcerated lesions of the skin, acne, rosacea; Infectious state (bacterial, viral, and fungal infections); diabetic subjects; ulcerative history and other gastrointestinal disorders; lactose allergy; galactose intolerance; ulcerative colonic pathology; myastenia gravis; live vaccine kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way.
The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.
Read the detailed description
Clinical research with two groups of ten volunteers one group with 5 days with local administration (cream, applied to healthy skin) one group with 5 days with systemic route of administration (per os)
- Being tested
- Hydrocortisone administration
- Keywords
- Hydrocortisone (cortisol), local administration of cortisol, systemic administration of cortisol, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone administrationDrug
Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
| Study group | Role | What they receive |
|---|---|---|
| Topical hydrocortisone administration | Active comparator | dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days) Receives: Drug: Hydrocortisone administration |
| Systemic hydrocortisone administration | Active comparator | tablets (once a day, 50 mg, morning, during 50 days) Receives: Drug: Hydrocortisone administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Measured: 7 days
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,
Measured: Day 12
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Measured: 7 days
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am
Measured: Day 12
Secondary outcomes (12)
blood concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
blood concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Measured: Day 12
blood concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
blood concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Measured: day 12
blood concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
blood concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am;
Measured: Day 12
saliva concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
saliva concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
saliva concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm
Measured: 7 days
saliva concentration of cortisol
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Measured: Day 12
saliva concentration of Adreno CorticoTrophic Hormone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Measured: Day 12
saliva concentration of DeHydroEpiAndrostérone
Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start13 Nov 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anti-doping Campaign, Detection of HydrocortisoneStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Collaborators
- French Anti-Doping Agency (AFLD), University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- AMIOT Virgile, MD, Study director, Hospital Regional Center of ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137302
- Sponsor's protocol ID
- CHRO 2019-04
- Acronym
- H-CORT
- Status last verified
- Dec 2020
- First submitted
- 22 Oct 2019
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8. doi: 10.1249/mss.0b013e3180dc992c.
PubMed 17805102Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13.
PubMed 19056411Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16.
PubMed 27643452Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.
PubMed 18048433
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
- ClinicalTrials.gov ID
- NCT04137302
- Acronym / sponsor ID
- H-CORT / CHRO 2019-04
- Keywords
- Hydrocortisone (cortisol), local administration of cortisol, systemic administration of cortisol, biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Collaborators
- French Anti-Doping Agency (AFLD), University Hospital, Tours
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 24 Oct 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.
The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way.
The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.
Detailed description
Clinical research with two groups of ten volunteers one group with 5 days with local administration (cream, applied to healthy skin) one group with 5 days with systemic route of administration (per os)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)
| Arm | Type | Receives |
|---|---|---|
| Topical hydrocortisone administration | Active comparator | Drug: Hydrocortisone administrationdermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days) |
| Systemic hydrocortisone administration | Active comparator | Drug: Hydrocortisone administrationtablets (once a day, 50 mg, morning, during 50 days) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male subjects
Key exclusion criteria (1 listed)
- asthmatic subjects or history of respiratory or cardiac pathology; use of corticosteroids in the past 6 months; high blood pressure; ulcerated lesions of the skin, acne, rosacea; Infectious state (bacterial, viral, and fungal infections); diabetic subjects; ulcerative history and other gastrointestinal disorders; lactose allergy; galactose intolerance; ulcerative colonic pathology; myastenia gravis; live vaccine kidney failure
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 |
|---|---|---|
| Hydrocortisone administrationHydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments | Drug | Systemic hydrocortisone administration, Topical hydrocortisone administration |
Primary outcome
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Time frame: 7 days
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
Time frame: Day 12
Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am,
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Time frame: 7 days
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm
Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
Time frame: Day 12
Isotope ratio mass spectrometry to study biomarkers urine level at 8 am
12 secondary outcomes
blood concentration of cortisol
Time frame: 7 days
blood concentration of cortisol
Time frame: Day 12
blood concentration of DeHydroEpiAndrostérone
Time frame: 7 days
blood concentration of DeHydroEpiAndrostérone
Time frame: day 12
blood concentration of Adreno CorticoTrophic Hormone
Time frame: 7 days
blood concentration of Adreno CorticoTrophic Hormone
Time frame: Day 12
saliva concentration of cortisol
Time frame: 7 days
saliva concentration of DeHydroEpiAndrostérone
Time frame: 7 days
saliva concentration of Adreno CorticoTrophic Hormone
Time frame: 7 days
saliva concentration of cortisol
Time frame: Day 12
saliva concentration of Adreno CorticoTrophic Hormone
Time frame: Day 12
saliva concentration of DeHydroEpiAndrostérone
Time frame: Day 12
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 7 Dec 2020.
- Background: PubMed 17805102Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8. doi: 10.1249/mss.0b013e3180dc992c.
- Background: PubMed 19056411Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13.
- Background: PubMed 27643452Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16.
- Background: PubMed 18048433Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.
- Individual participant dataSharing planned: No
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.
AMIOT Virgile, MD study director
Hospital Regional Center of ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone administration in people with Anti-doping Campaign, Detection of Hydrocortisone, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 1 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 7 Dec 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT04137302, which also lists 4 linked publications.
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 7 Dec 2020.