Pharmacokinetics of sublingual testosterone, female sexual arousal, Vaginal Pulse Amplitude (VPA) Farmacokinetiek sublinguale testosteron, seksuele opwinding bij vrouwen, vaginale pulse amplitude (VPA)
Conditions
Interventions
Three doses of sublingual testosterone and onde dose of placebo. Medication administration is separated by a 48 hour washout period.
Sponsors
Emotional Brain BV
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent; 2. Female 21-40 years of age; 3. Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically relevant; 4. Subject must be heterosexually oriented; 5. BMI ≥ 18 and ≤ 30 kg/m2; 6. Venous access sufficient to allow blood sampling as per protocol.
Exclusion criteria
Exclusion criteria: 1. Sexual dysfunction as determined by Sexual Function Questionnaire (SFQ) diagnostic scores (within ‘high probability of dysfunction’ or ‘possibility of dysfunction’ ranges) for all functional domains (desire, arousal-lubrication, arousal-sensation, orgasm and pain) as described by Quirk et al. 2005; 2. Subjects who had used testosterone therapy within 6 months before study entry; 3. (A history of) hormone-dependant malignancy; 4. Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva); 5. Use of oral contraception containing 50 μg estrogen or more; 6. Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women prior to the administration of study medications); 7. A pelvic inflammatory disease or an untreated vaginal infection at screening; 8. Lactating, or subjects who have given birth in the previous 6 months; 9. Previous prolapse and incontinence surgery affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement; 10. Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns; 11. (History of) endocrine disease; 12. (History of) severe neurological problems, current severe neurological problems, or other mild or moderate neurological problems which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if she took part in the trial; 13. Treatment for a current serious psychiatric disorder (e.g., schizophrenia, psychosis ) or treatment for obsessive compulsive disorder, anorexia nervosa, bulimia nervosa and/or social anxiety neurosis; 14. Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity; 15. (History of) myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months; 16. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 60-80 bpm in rest, > 90-115 bpm in moderate exercise), or other significant abnormality observed on ECG; 17. Systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 80 mmHg; 18. Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir; 19. Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine; 20. Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal; 21. Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula; 22. A substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study; mild or moderately alcohol drinking behavior is allowed, only 12 hours before the experimental days is alcohol drinking not allowed. Three weeks before the start of the experimental day is the taking of any recreational drug not allowed. Smoking is allowed; 23. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires; 24. Any other clinically significant abnormality or condition which in the opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To establish the lowest effective dose using physiological and subjective measures of sexual arousal; 2. To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three doses of sublingual testosterone. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of three different doses of sublingual testosterone on the duration of increased physiological and subjective measures of sexual arousal. | — |
Contacts
Public ContactK. Rooij, van
Emotional Brain bv
Outcome results
None listed