Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning.
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 (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. 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, 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 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, 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 h
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 using SSRIs. ;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 compare subjective, physiological and neuropsychological responding at home with the laboratory setting. - 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