Hypoactive sexual desire disorder and female sexual arousal disorder
Conditions
Sponsors
Emotional Brain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects must have signed the Informed Consent Form. • Subjects must be between 21 and 45 years of age • Subjects must have experienced low sexual arousal for at least six months prior to study entry. The diagnosis will be made by an experienced sexologist. • Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically irrelevant. • Subjects must be premenopausal Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of oral contraception containing anti-androgens (Diane-pill). 2. Use of oral contraception containing 50 µg estrogen or more. 3. Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women of childbearing potential prior to the administration of study medications). 4. A pelvic inflammatory disease or an untreated vaginal infection at screening. 5. Lactating or subjects who have given birth in the previous 6 months. 6. Previous prolapse and incontinence surgery. 7. Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns. 8. History of endocrinological treatment or current endocrinological treatment (with the exception of the use oral contraceptives). 9. History of neurological treatment or current neurological treatment. 10. History of psychiatric treatment or current psychiatric treatment. 11. History of childhood sexual abuse. 12. Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity. 13. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months. No limiting or unstable angina pectoris. 14. No clinically relevant deviations in ECG parameters as judged by the medical investigator. 15. Use of medicinal herbs such as St John’s wort, Ginkgo Biloba and nutrition containing grapefruit. 16. Severe chronic or acute liver disease, impairment according to Child-Pugh categorization. 17. Exposure to nitric oxides. 18. 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. 19. Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices. 20. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires. 21. Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if she took part in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate effects of sexual arousal induced by an erotic film during treatment of testosterone combined with sildenafil on functional brain activity in healthy female subjects with and without FSD.;Secondary Objective: To evaluate effects of differing levels of attentional engagement on brain activity during erotic film viewing.;Primary end point(s): To assess activity of functional brain regions related to testosterone induced sexual arousal To assess the role of differing levels of attention toward sexual stimuli on activity of brain regions associated with sexual arousal. To evaluate the self-report ratings of sexual functioning | — |
Countries
Netherlands
Outcome results
None listed