Ergogenic effects of pseudoephedrine on edurance performance in relation to the determination of threshold values in urine and capillary and venous blood

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universiteit Gent

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

27 Aug 2025 → ongoing

Decision date (initial)

2025-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ghent University

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy

To identify the effects of a full dose (240 mg) of Pseudoephedrine on cycling performance after an exhausting race simulation in a highly trained population.

Secondary objectives 3

1. To figure out the physiological mechanisms that lead to the changes in performance.
2. To determine separate Pseudoephedrine concentration thresholds dependent on the method of sample collection corresponding to the maximal measured concentration
3. To determine if only a half dose (120 mg) of pseudoephedrine ingestion also improves performance.

Conditions and MedDRA coding

Healthy volunteers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. VO2max > 60ml/min/kg bodymass (men)
2. VO2max > 50ml/min/kg bodymass (women)
3. Having a mean trainingvolume of more than 10 hours per week of which > 3 hours of cycling training
4. Medical approval to compete in competition sport
5. Between 18-40 years of age
6. Actively using combined (estrogen and progestogen containing) or progestogen-only hormonal birth control according to the guidelines for longer than 1 month (only for women)
7. Dutch speaking

Exclusion criteria 17

1. Engaging in competition during the full duration of the study
2. Use of other products for nasal decongestion, appetite suppressants, stimulant medications (psychostimulants) of the amphetamine type and medications for diabetes, or high blood pressure.
3. Hypersensitivity to the active substance or to any of the excipients
4. Diabetes
5. Enlarged prostate or multiple symptoms that could indicate an enlarged prostate
6. Unable to give informed consent
7. Enrolled in another drug trial
8. Injuries sustained within the 3 months prior to the study that resulted in a break from sports participation for 2 weeks or longer
9. Ingestion of supplements, medication and/or drugs in the last week leading up to the study and during the study
10. Vaccination or blood donation in the last 3 weeks leading up to the study and during the study
11. Pregnant women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)
12. Breastfeeding women
13. Smoking
14. History of cardiac arrhythmias, coronary artery disease, cerebrovascular accident (stroke), severe hypertension, hyperthyroidism (overactive thyroid), severe renal insufficiency (impaired kidney function) and glaucoma (increased intraocular pressure)
15. Use of antidepressants such as monoamine oxidase (MAO) inhibitors or tricyclic antidepressants that should not be combined with pseudoephedrine Phenelzine (Nardil zine), Moclobemide, Amitriptyline (Redomex), Clomipramine (Anafranil), Dosulepin (Prothiaden), Imipramine (Tofranil), Nortriptyline (Nortrilen))
16. Rare hereditary conditions such as galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption
17. Use of products containing aluminium hydroxide (Maalox Antacid, Gaviscon)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in time trial duration (and average power output) when the placebo trial (0 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine

Secondary endpoints 5

1. Changes in physiological parameters (cardiovascular, oxidative and metabolic) during the 90’ long cycling race simulation when the placebo trial (0 mg) is compared to the trial with ingestion of 120 mg Pseudoephedrine
2. Changes in physiological parameters (cardiovascular, oxidative and metabolic) during the 90’ long cycling race simulation when the placebo trial (0 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine
3. The upper limit of the 95% CI of the mean maximal measured blood/urine pseudoephedrine concentration after ingestion of 240 mg of pseudoephedrine for each sampling method (TASSO+, VAMS, DBS, Venapuncture and urine collection)
4. Change in time trial duration (and average power output) when the half-dose trial (120 mg) is compared to the trial with ingestion of 0 mg Pseudoephedrine.
5. Change in time trial duration (and average power output) when the half-dose trial (120 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universiteit Gent

Sponsor organisation

Universiteit Gent

Address

Corneel Heymanslaan 10

City

Gent

Postcode

9000

Country

Belgium

Scientific contact point

Organisation

Universiteit Gent

Contact name

Mattice Sablain

Public contact point

Organisation

Universiteit Gent

Contact name

Mattice Sablain

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications