problems with sexal functioning Sexual dysfunction
Conditions
Interventions
Two interventions will be performed on all participants:
1. Testosterone (0.5 mg) cyclodextrin administered sublingually as a solution,
followed 2.5 hours later by an encapsulated tablet containing
this formula is
designed to release the inner-core buspirone at about 2.5 hours after tablet
intake. After this time delay of 2.5 hours, the buspirone is released
immediately, rather than being rel
Sponsors
Clinical Research Organisations
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Female 18-35 years of age (inclusive) 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. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg. 3. Systolic blood pressure 30);Other medical conditions 10. Liver- and/or renal insufficiency 11. Current clinically relevant endocrine disease 12. 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 buspirone and/or testosterone use 13. (A history of) hormone-dependant malignancy;Psychological/psychiatric factors 14. 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 admission period. Recreational drug use is not allowed beginning 3 weeks before the start of the admission period until follow up. Smokers are not allowed to participate.;Concomitant medication 15. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir) 16. Subjects who are taking CYP3A4-inducers (eg, fenytoïne, fenobarbital, st Johns Wort, rifampicine) 17. Use of serotonergic drugs (eg, trazodon, fluvoxamine) 18. Use of testosterone therapy within 6 months before study entry 19. 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);Drug/food interaction 20. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study;General 21. Illiteracy, unwillingness, or inability to follow study procedures 22. 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 buspirone and/or testosterone use. 23. 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 buspirone (F2 >= 75% of Cmax F1); • AUC0-1590 of total testosterone (F2 >= 75% of AUC0-1590 F1); • AUC0-1590 of free testosterone (F2 >= 75% of AUC0-1590 F1); • AUC0-infinity of buspirone (F2 >= 75% of AUC0-infinity F1); | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the time frame in which the mint flavored testosterone coating is dissolved. | — |
Countries
Netherlands
Outcome results
None listed