Steroid metabolism Nutritional, Metabolic, Endocrine
Conditions
Interventions
The trial is an open-label trial which means that every participant will receive the treatment and will know what is the treatment. A treatment with testosterone gel will be administered for 28 days.
Sponsors
Research and Expertise in antiDoping sciences - Université de Lausanne
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged 20-40 years old 3. Body mass index between 18 and 30 kg/m2 4. Hemoglobin concentration between 12 and 16 g/dL 5. Negative pregnancy test at screening 6. Basal testosterone concentration = 1.5 nmol/L 7. Regular menstrual cycles (26-32 days) 8. Normal biological balance (complete blood count, liver function (ASAT / ALAT), CRP, renal function (creatinine)) 9. Normal hormone balance (LH, FSH, SHBG, cortisol, prolactin)
Exclusion criteria
Exclusion criteria: 1. Hypertension (SBP> 140 and DBP> 90 mmHg) 2. Regular intake of tobacco (max 1 cigarette / day) or alcohol (max 1 drink / week) 3. Regular intake of anabolic or ergogenic drugs 4. Holder of a license in a sports discipline 5. Current acne or hirsutism deemed clinically significant 6. Dyslipidemia or hypercholesterolemia 7. Hyperprolactinaemia 8. Endocrine or metabolic disease 9. Tumor of pituitary gland or hypothalamus 10. Contraindications to the class of the substance administered (hypersensitivity or allergy to the active substance or to any of the excipients) 11. Treatment with synthetic anti-thyroid or thyroid hormones 12. Treatment with ketoconazole, anticoagulants, ACTH, corticosteroids 13. Cardiovascular, hepatic, renal or biliary disease 14. Current use of hormonal contraceptives or during the two months preceding the study 15. Pregnancy present or envisaged within 6 months after the end of the study 16. Breastfeeding 17. Eating disorders 18. Previous participation in another study in the last 30 days 19. Sports competition scheduled within 9 months after the end of the study 20. Donation of blood during the last 3 months 21. Migraine 22. Neoplasia or history of neoplasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum testosterone concentration will be measured using UHPLC-MS/MS during the whole study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary and serum steroid profile with GC-MS and UHPLC-MS/MS before, during and after treatment. 2. Untargeted metabolomics study with UHPLC-HRMS for discovery of potential biomarkers of testosterone abuse with comparison of metabolic profile before, during and after treatment. 3. Analyses of urine samples with IRMS during the treatment phase. 4. Body composition measurement with DEXA scan before and after treatment. 5. Hematological profile with Sysmex XN-1000 during the whole study. 6. Endocrinological profile (LH, FSH, hCG, SHBG) during the whole study measured with clinical chemistry. 7. Self-esteem and quality of life using specific questionnaires (Rosenberg self-esteem scale and SF-96 questionnaire) before and after treatment. | — |
Countries
Switzerland
Contacts
Public ContactOlivier Salamin
Outcome results
None listed