Selective serotonin reuptake inhibitors (SSRIs), Female sexual dysfunction (FSD), Hypoactive sexual desire disorder, Female sexual arousal disorder
Conditions
Interventions
Lybrido, Lybridos and placebo.
The placebo regime (duration 4 weeks), the Lybrido regime (duration 4 weeks), and the Lybridos regime (duration 4 weeks) are separated by a one- till four-week washout
Sponsors
Emotional Brain BV
Eligibility
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.
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, lithium, pethidin, any medicine belonging to the triptans (i.e. sumatriptan); 24. A substance abuse disorder that in the opinion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Lybrido and Lybridos on subjective sexual experience in the domestic setting in healthy female subjects Female Sexual Dysfunction using SSRIs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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 in combination with SSRI use; 2. To investigate differences in attentional bias for erotic stimuli in different subgroups of women with FSD and SSRI induced FSD, and the influence of Lybrido and Lybridos herein; 3. To investigate differences in subjective, physiological and neuropsychological responding at home or in the laboratory; 4. To evaluate the safety of Lybrido and Lybridos in the domestic setting. | — |
Contacts
Public ContactK. Rooij, van
Emotional Brain bv
Outcome results
None listed