Establishment of the female steroid profile and impact of transdermal testosterone administration on the steroidal metabolism: open-label trial

Research and Expertise in antiDoping sciences - Université de Lausanne0 个研究点目标入组 14 人开始时间: 2019年1月11日最近更新: 2021年5月24日

适应症

试验速览

•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)

•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

发起方

Research and Expertise in antiDoping sciences - Université de Lausanne