problems with sexual functioning Sexual dysfunction
Conditions
Interventions
Two interventions will be performed on all participants:
- Administration of sublingual testosterone (0.5 mg) and an oral tablet
containing sildenafil (50 mg).
- Administration of a single fixed-com
Sponsors
Emotional Brain BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Female 18-35 years of age 3. Healthy based on medical history, physical examination, laboratory values and vital signs 4. Body mass index (BMI) >= 18 kg/m2 and
Exclusion criteria
Exclusion criteria: Cardiovascular conditions 1. Any underlying cardiovascular condition, including unstable angina pectoris 2. History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months 3. Uncontrolled atrial fibrillation/flutter at screening, or other significant abnormality observed on electrocardiogram (ECG) 4. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure > 90 mmHg. 5. Systolic blood pressure 30);Other medical conditions 12. Liver- and/or renal insufficiency 13. Current clinically relevant endocrine disease 14. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for sildenafil and/or testosterone use 15. (A history of) hormone-dependant malignancy;Psychological/psychiatric factors 16. 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 moderate alcohol consumption is allowed but must be stopped 24 hours before the experimental visit. Recreational drug use is not allowed beginning 3 weeks before the start of the experimental visit until follow up. Smoking is not allowed. ;Concomitant medication 17. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir) 18. Subjects who are taking CYP3A4-inducers (eg, carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine) 19. Use of nitrates or nitric oxide donor compounds 20. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), use of corticosteroids) 21. Use of testosterone therapy within 6 months before study entry;Drug/food interaction 22. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study;General 23. Illiteracy, unwillingness, or inability to follow study procedures 24. Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the participant*s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for sildenafil and/or testosterone use. 25. Participation in any other clinical drug study in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Cmax of total testosterone (F2 >= 75% of Cmax F1); • Cmax of free testosterone ( F2 >= 75% of Cmax F1); • Cmax of sildenafil (F2 >= 75% of Cmax F1); • AUC0-infinity of total testosterone (F2 >= 75% of AUC0-infinity F1); • AUC0-infinity of free testosterone (F2 >= 75% of AUC0-infinity F1); • AUC0-infinity of sildenafil (F2 >= 75% of AUC0-infinity F1); | — |
Secondary
| Measure | Time frame |
|---|---|
| • To investigate the time frame in which the testosterone coating of the combination tablet is dissolved sublingually. | — |
Countries
Netherlands
Outcome results
None listed