A double blind, randomized, cross-over placebo controlled 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 in combination with SSRI use. - Lybrido(s) and SSRIs@Home
- Conditions
- Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning.
- Registration Number
- EUCTR2009-016790-15-NL
- Lead Sponsor
- Emotional Brain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
1Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva);
2Use of oral contraception containing 50 µg estrogen or more;
3Pregnancy, 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);
4A pelvic inflammatory disease or an untreated vaginal infection at screening;
5Lactating or subjects who have given birth in the previous 6 months;
6Previous prolapse and incontinence surgery affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement;
7Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
8Childhood sexual abuse before the age of 16 (CSA as defined by the decision tree in Appendix 4);
9PTSS as a result of sexual abuse (using the M.I.N.I plus 5.0.0 questionnaire)
10History of endocrine disease;
11History 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;
12Treatment 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.
13Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
14History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
15Uncontrolled 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;
16Systolic 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;
17Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
18Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
19Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal;
20Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula;
21Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression)
22Subjects who are taking nitrates or nitric oxide donors;
23Subjects 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).
24A 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>-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.<br>-To compare subjective, physiological and neuropsychological responding at home with the laboratory setting.<br>-To evaluate the safety of Lybrido and Lybridos in the domestic setting.<br>;Primary end point(s): Subjective ratings of sexual functioning (questionnaires & diary)
- Secondary Outcome Measures
Name Time Method