Healthy VolunteersPhase 1SPOL1NCT04166786

Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption

A Phase 1 study testing Testosterone gel and Ethanol Solution in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Background: Testosterone is an anabolic steroid widely known to improve physical performance. Its consumption is banned by the World Anti-Doping Agency (WADA). The steroid profile is one of the components of the Athlete's Biological Passport (ABP), which consists of selected biological variables that indirectly reveal… Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Testosterone gel and Ethanol Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteSpain
Study dates: 6 May 2019to 26 Sep 2019
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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Caucasian men aged 18 to 40 years.
Clinical history and physical examination demonstrating no organic or psychiatric disorders.
The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 100 kg.
Understanding and accepting the study procedures and signing the informed consent.
Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each session and until the end of the study.
Subjects with social or recreational alcohol consumption, at least 3 Standard Drink/week and subjects with experience in several drunkenness.
Volunteers with normal steroidal profile for Caucasian population (0.7 ≤T / E ≤3)

Who cannot join

Not meeting the inclusion criteria.
Allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance of Testogel gel®, which is synthesized from soy, or to any of the excipients or to vaseline ointment.
Subjects with intolerance or adverse reactions to ethanol.
History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
History or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by it, may pose a risk to the subjects or interfere with the objectives of the study. Especially history of epilepsy and migraine, edema, hypertension, diabetes mellitus, hypercalcemia or polyglobulia.
History of psychiatric disorders.

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History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
Subjects with contraindications to treatment with the study drugs (according to the respective technical data sheets). Especially a history of breast cancer, liver cancer, suspicion or confirmation of prostate carcinoma Subjects and subjects who have suffered a hospitalization caused by alcohol intoxication or who have received treatment for drunkenness
Having suffered any organic disease or major surgery in the three months prior to the study start.
Symptoms compatible with a prostatic syndrome: increase in the number of urinations, difficulty to initiate urination, thinner and less potent urine stream, urination in several times, incomplete emptying of urine feeling.
Prostate-specific antigen (PSA) values outside the normal range for the volunteer's age.
Subjects with positive serology to Hepatitis B, C or HIV.
Presence of bacterial, fungal or deep cuts in the area of skin chosen for cutaneous applications.
Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
Smokers of more than 20 cigarettes per day.
Taking more than 40 g of alcohol a day
Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the start of the study.
Ingestion of vitamin supplements or antioxidants or Non-Steroidal Anti-Inflammatory Drugs (NSAID) in the two weeks preceding the study.
Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

IMIM (Hospital del Mar Medical Research Institute)
Barcelona, 08003

Other trials in Spain

About this study

Official title: Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers

Background:

Testosterone is an anabolic steroid widely known to improve physical performance. Its consumption is banned by the World Anti-Doping Agency (WADA). The steroid profile is one of the components of the Athlete's Biological Passport (ABP), which consists of selected biological variables that indirectly reveal the effects of doping. Alcohol consumption has been proved to alter the steroid profile and this may lead to the use of ethanol as a masking agent for testosterone administration.

Hypothesis:

Ratios of different testosterone biomarkers vary after ethanol administration: [6-hydroxy-androsterone-3-glucuronide (6OH-Andros3G) / epitestosterone-glucuronide (EG)] and [6-hydroxy-etiocholanolone-3-glucuronide (6OH-Etio3G) / EG] decrease, while [testosterone-glucuronide (TG) / EG] increases.

Primary objective:

To evaluate if the combination of the markers TG, EG, 6OH-Andros3G and 6OH-Etio3G, as well as ethyl glucuronide (EtG) and ethyl sulfate (EtS), can be routinely used to differentiate between changes in the steroid profile due exclusively to the consumption of alcohol and those produced when alcohol is consumed during a testosterone administration.

Secondary objectives:

To explore the potential of the simultaneous determination of both phase I and phase II metabolites in alternative matrices (plasma from blood samples collected as for the haematological module of ABP, or saliva) in the screening of testosterone misuse.
To look for the differences into a comprehensive steroid profile (determined in urine, plasma and saliva) between samples collected after testosterone administration and after the combination of testosterone and ethanol.

Methods:

Phase I, single-blind, crossover-design clinical trial, placebo controlled, with 4 conditions randomly assigned in male healthy caucasian subjects with a wash-out period between treatments.

Conditions: Healthy Volunteers
Being tested: Testosterone gel, Ethanol Solution, Testosterone placebo (vaseline), Ethanol placebo (lemon-flavoured water)
Keywords: Testosterone, Ethanol, 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 gelDrug
Also called Testogel 50 mg®
Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days.
Ethanol SolutionDrug
Also called Vodka Absolut®
Subjects receive a daily administration of 30 g of ethanol (94 mL of Vodka Absolut® diluted in 300 mL of lemon-flavoured water Fontvella®) during 3 days.
Testosterone placebo (vaseline)Drug
Also called Vaselina Pura Pege®
Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days.
Ethanol placebo (lemon-flavoured water)Drug
Also called Lemon flavored-water Fontvella®
Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella® during 3 days.

Study groups in NCT04166786
Study group	Role	What they receive
Testosterone + Ethanol	Experimental	Subjects receive a 3-day treatment with testosterone in combination with ethanol consumption. Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained. Receives: Drug: Testosterone gel; Drug: Ethanol Solution
Testosterone placebo + Ethanol	Other	Subjects receive a 3-day treatment with testosterone placebo (vaseline) in combination with ethanol consumption. Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained. Receives: Drug: Ethanol Solution; Drug: Testosterone placebo (vaseline)
Testosterone + Ethanol placebo	Other	Subjects receive a 3-day treatment with testosterone in combination with ethanol placebo (lemon-flavoured water). Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained. Receives: Drug: Testosterone gel; Drug: Ethanol placebo (lemon-flavoured water)
Testosterone placebo + Ethanol placebo	Placebo comparator	Subjects receive a 3-day treatment with testosterone placebo (vaseline) in combination with ethanol placebo (lemon-flavoured water). Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained. Receives: Drug: Testosterone placebo (vaseline); Drug: Ethanol placebo (lemon-flavoured water)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in steroid profile in urine
Variation of the concentration of different endogenous steroids (testosterone, epitestosterone, androsterone, etiocholanolone, 3a,5a-androstanediol, 3a,5b-androstanediol, DHEAS, 5PTS, 5PDS, PTG, PDG) in urine before and after treatment administration.
Measured: From baseline (pre-administration) to 48 hours after last administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24 hours each day, and 24-48 hours post-administration last day)
Change in new steroid profile markers in plasma
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in plasma before and after treatment administration.
Measured: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Change in new steroid profile markers in saliva
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in saliva before and after treatment administration.
Measured: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Change in Ethyl glucuronide in urine
Variation of the concentration of Ethyl glucuronide in urine before and after treatment administration.
Measured: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)
Change in Ethyl sulfate in urine
Variation of the concentration of Ethyl sulfate in urine before and after treatment administration.
Measured: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 201926 Sep 2019

First posted18 Nov 2019
Study start6 May 2019
Primary completion26 Sep 2019
Study completion26 Sep 2019

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: Randomised
Intervention model: Crossover
Model description: Subjects receive 4 different treatment conditions (testosterone+ethanol placebo, ethanol+testosterone placebo, testosterone+ethanol, and placebo testosterone+placebo ethanol), separated by a wash-out period of 15 days. The order of the treatment conditions is randomly assigned.
Masking: Single blind
Who is masked: Participant
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04166786
Sponsor's protocol ID: IMIMFTCL/SPOL/1
Acronym: SPOL1
Status last verified: Sep 2019
First submitted: 7 Nov 2019
Last updated: 18 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers
ClinicalTrials.gov ID: NCT04166786
Acronym / sponsor ID: SPOL1 / IMIMFTCL/SPOL/1
Conditions: Healthy Volunteers
Keywords: Testosterone, Ethanol, 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: 6 May 2019 (actual)
Primary completion: 26 Sep 2019 (actual)
Study completion: 26 Sep 2019 (actual)
First posted: 18 Nov 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:

Hypothesis:

Primary objective:

Secondary objectives:

To explore the potential of the simultaneous determination of both phase I and phase II metabolites in alternative matrices (plasma from blood samples collected as for the haematological module of ABP, or saliva) in the screening of testosterone misuse.
To look for the differences into a comprehensive steroid profile (determined in urine, plasma and saliva) between samples collected after testosterone administration and after the combination of testosterone and ethanol.

Methods:

Phase I, single-blind, crossover-design clinical trial, placebo controlled, with 4 conditions randomly assigned in male healthy caucasian subjects with a wash-out period between treatments.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4
Model description: Subjects receive 4 different treatment conditions (testosterone+ethanol placebo, ethanol+testosterone placebo, testosterone+ethanol, and placebo testosterone+placebo ethanol), separated by a wash-out period of 15 days. The order of the treatment conditions is randomly assigned.

Arm	Type	Receives
Testosterone + Ethanol	Experimental	Drug: Testosterone gel, Drug: Ethanol SolutionSubjects receive a 3-day treatment with testosterone in combination with ethanol consumption. Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained.
Testosterone placebo + Ethanol	Other	Drug: Ethanol Solution, Drug: Testosterone placebo (vaseline)Subjects receive a 3-day treatment with testosterone placebo (vaseline) in combination with ethanol consumption. Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained.
Testosterone + Ethanol placebo	Other	Drug: Testosterone gel, Drug: Ethanol placebo (lemon-flavoured water)Subjects receive a 3-day treatment with testosterone in combination with ethanol placebo (lemon-flavoured water). Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained.
Testosterone placebo + Ethanol placebo	Placebo comparator	Drug: Testosterone placebo (vaseline), Drug: Ethanol placebo (lemon-flavoured water)Subjects receive a 3-day treatment with testosterone placebo (vaseline) in combination with ethanol placebo (lemon-flavoured water). Subjects have to collect urine in different fractions until 48h post-administration. Blood and saliva samples are also obtained.

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy Caucasian men aged 18 to 40 years.
Clinical history and physical examination demonstrating no organic or psychiatric disorders.
The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 100 kg.
Understanding and accepting the study procedures and signing the informed consent.

Key exclusion criteria (20 listed)

Not meeting the inclusion criteria.
Allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance of Testogel gel®, which is synthesized from soy, or to any of the excipients or to vaseline ointment.
Subjects with intolerance or adverse reactions to ethanol.
History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
History or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by it, may pose a risk to the subjects or interfere with the objectives of the study. Especially history of epilepsy and migraine, edema, hypertension, diabetes mellitus, hypercalcemia or polyglobulia.

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 gelAlso: Testogel 50 mg®Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days.	Drug	Testosterone + Ethanol, Testosterone + Ethanol placebo
Ethanol SolutionAlso: Vodka Absolut®Subjects receive a daily administration of 30 g of ethanol (94 mL of Vodka Absolut® diluted in 300 mL of lemon-flavoured water Fontvella®) during 3 days.	Drug	Testosterone + Ethanol, Testosterone placebo + Ethanol
Testosterone placebo (vaseline)Also: Vaselina Pura Pege®Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days.	Drug	Testosterone placebo + Ethanol, Testosterone placebo + Ethanol placebo
Ethanol placebo (lemon-flavoured water)Also: Lemon flavored-water Fontvella®Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella® during 3 days.	Drug	Testosterone + Ethanol placebo, Testosterone placebo + Ethanol placebo

Primary outcome

Change in steroid profile in urine
Time frame: From baseline (pre-administration) to 48 hours after last administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24 hours each day, and 24-48 hours post-administration last day)
Variation of the concentration of different endogenous steroids (testosterone, epitestosterone, androsterone, etiocholanolone, 3a,5a-androstanediol, 3a,5b-androstanediol, DHEAS, 5PTS, 5PDS, PTG, PDG) in urine before and after treatment administration.
Change in new steroid profile markers in plasma
Time frame: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in plasma before and after treatment administration.
Change in new steroid profile markers in saliva
Time frame: From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)
Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in saliva before and after treatment administration.
Change in Ethyl glucuronide in urine
Time frame: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)
Variation of the concentration of Ethyl glucuronide in urine before and after treatment administration.
Change in Ethyl sulfate in urine
Time frame: From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)
Variation of the concentration of Ethyl sulfate in urine before and after treatment administration.

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 18 Nov 2019.
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.

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 gel and Ethanol Solution 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 8 inclusion and 20 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 18 Nov 2019. 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. Some participants in this study may receive a placebo. 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?

Change in steroid profile in urine (time frame: From baseline (pre-administration) to 48 hours after last administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24 hours each day, and 24-48 hours post-administration last day)). The study lists 5 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 NCT04166786.

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 18 Nov 2019.