Hypoactive sexual desire disorder and female sexual arousal disorder in combination with SSRI use.
Conditions
Sponsors
Emotional Brain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder and/or Female Sexual Arousal Disorder and/or SSRI induced sexual disfunctioning; subjects must have experienced low sexual arousal and / or low sexual desire for at least one month prior to study entry according to DSM IV criteria. 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. 7. Subjects must have developed FSD before using SSRIs or developed FSD during the usage of a SSRI. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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; 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 and of fertility-promoting treatment); 9 History of neurological treatment or current neurological treatment; 10 History of serious psychiatric treatment (e.g.,schizophrenia, psychosis) or current treatment for psychiatric disorders like obsessive compulsive disorder, and anorexia nervosa. 11 Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity; 12 History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months; 13 Uncontrolled atr ial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG; 14 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. 15 Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol 16 Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir 17 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine 18 Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment; 19 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) 20 Subjects who are taking nitrates or nitric oxide donors; 21 Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, Trazodon, TCAs, tramadol, any medicine belonging to the triptans (i.e. sumatriptan). 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 Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices; 24 Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires; 25 Any other clinically signifi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of Lybrido and Lybridos on subjective sexual experience in the domestic setting in healthy female subjects with Female Sexual Dysfunction in combination with SSRI use .;Secondary Objective: - To evaluate efficacy of Lybrido and Lybridos on physiological sexual responding (vaginal and clitoral) in the domestic setting in different subgroups of women with FSD using SSRIs. - To investigate differences in attentional bias for erotic stimuli in different subgroups of women with FSD using SSRIs, and the influence of Lybrido and Lybridos herein. - To investigate differences in subjective, physiological and neuropsychological responding at home or in the laboratory. - To evaluate the safety of Lybrido and Lybridos in the domestic setting. ;Primary end point(s): Subjective ratings of sexual functioning (questionnaires & diary) | — |
Countries
Netherlands
Outcome results
None listed