@home: a study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subjects with Female Sexual Dysfunction and SSRI usage.

1. Provision of written informed consent;

2. Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning. The diagnosis will be made by an experienced psychologist/sexologist;

3. Usage of a SSRI for at least 3 months;

4. The SSRI must be on a stable dose for at least 6 weeks;

5. 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;

6. Subjects must have a heterosexual relationship.

1. Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva);

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 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 affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement;

7. Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;

8. Childhood sexual abuse before the age of 16 (CSA as defined by the decision tree in Appendix 4);

9. PTSS as a result of sexual abuse (using the M.I.N.I plus 5.0.0 questionnaire);

10. History of endocrine disease;

11. 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;

12. 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;

13. Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;

14. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;

15. 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;

16. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects with age > 60 years and without diabetic mellitus, familiar hypercholesterolemia or cardiovascular disease: Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 90 mmHg (According to the CBO-guideline hypertension (CBO.2000a)). Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg;

17. Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;

18. Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;

19. Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal;

20. Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula;

21. Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression);

22. Subjects who are taking nitrates or nitric oxide donors;

23. Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, Trazodon, TCAs, tramadol, lithium, pethidin, any medicine belonging to the triptans (i.e. sumatriptan);

24. 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;

25. Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices;

26. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;

27. 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;

28. Subjects who do not have easy access to a/their partner (for example because the partner works on a drilling platform at sea);

29. Subjects who are experiencing vision impairment, like partial or complete blindness or color blindness;

30. Subjects with a body mass index (BMI)>35 kg/m2;

31. Subjects who do not have easy access to the internet;

32. Subjects with a peri menopausal hormonal status;

33. Clinical suspicion of carcinoid syndrome (spells of flushing, diaphoresis and abdominal cramps);

34. History of serotonin syndrome.