@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.|
|- candidate number||4225|
|- NTR Number||NTR1495|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-okt-2008|
|- Secondary IDs||EB 072 Emotional Brain|
|- Public Title||@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.|
|- Scientific Title||Lybrido(s) and SSRIs @Home:
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.
|- hypothesis||In the present study we will investigate the efficacy of Lybrido and Lybridos in one group of subjects with FSD using SSRIs in the laboratory and in the domestic setting of these subjects. We will measure subjective, physiological and neuropsychological measures of sexual functioning, in the Emotional Brain laboratory and in the homes of the subjects, which enables us to compare different responding to subjective, physiological and neuropsychological measures in these two settings. To this end, we have developed a portable self-operated laboratory which can measure vaginal and clitoral blood flow/volume in response to neutral and erotic film clips, and attention for erotic stimuli.
-Subjects with SSRI induced FSD will have low attention for sexual stimuli.
-Subjects with SSRI induced FSD will benefit more from Lybridos compared to Lybrido and placebo.
-Subjects who already experienced FSD before the usage of SSRIs and have low attention to sexual stimuli will benefit more from Lybrido compared to Lybridos and placebo.
-Subjects who already experienced FSD before the usage of SSRIs and have high attention to sexual stimuli will benefit more from Lybridos compared to Lybrido and placebo.
-The attention for sexual stimuli is SSRI dose-related; the higher the dose the lower the attention for sexual stimuli.
Subjective and genital measures of sexual arousal will be significantly larger at home compared to the laboratory on site.
|- Healt Condition(s) or Problem(s) studied||Selective serotonin reuptake inhibitors (SSRIs), Female sexual dysfunction (FSD), Hypoactive sexual desire disorder, Female sexual arousal disorder|
|- Inclusion criteria||- For inclusion in the study, heterosexual women (pre-, and postmenopausal) with Hypoactive Sexual Desire Disorder (HSDD) in combination with SSRI use must fulfil the following criteria:|
1. Provision of written informed consent.
2. Female 21 Ė 70 years of age with Hypoactive Sexual Desire Disorder and/or SSRI induced sexual disfunctioning (comorbidity with Female Sexual Arousal Disorder (FSAD) and/or orgasmic disorder is allowed); subjects must have experienced 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 HSDD before using SSRIs or developed HSDD during the usage of a SSRI.
|- Exclusion criteria||- Any of the following is regarded as a criterion for exclusion from the study.
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 major depression;
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 atrial 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, fenytoÔne, 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, , 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 subjectís 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 significant abnormality or condition which in the opinion of investigator would interfere with the participantís 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;
26. Subjects who do not have easy access to a/their partner (for example because the partner works on a drilling platform at sea);
27. Subjects who are experiencing vision impairment, like partial or complete blindness or color blindness;
28. Subjects with a body mass index (BMI)>35 kg/m2;
29. Subjects who do not have easy access to the internet;
30. Subjects with a peri menopausal hormonal status.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-okt-2008|
|- planned closingdate||10-okt-2009|
|- Target number of participants||40|
|- Interventions||Lybrido, Lybridos and placebo for 1 year.|
|- Primary outcome||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 outcome||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.
|- Timepoints||In 3 arms, a total of 40 subjects receive each investigational drug separately for a duration of four weeks. The periods are separated by a one- till four-week washout period. |
|- Trial web site||http://www.emotionalbrain.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. K. Rooij, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K. Rooij, van|
|- Sponsor/Initiator ||Emotional Brain BV|
(Source(s) of Monetary or Material Support)
|Emotional Brain BV|
|- Brief summary||In 3 arms, a total of 40 subjects receive each investigational drug separately for a duration of four weeks. 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 period. |
The order in which subjects undergo the 4 week medication regimes is randomized following a Latin Square design.
At the beginning of each medication regime, subjects take home a mobile psychophysiological laboratory for 3 measurements in the domestic setting. The domestic part of the study is preceded by three experimental days (psychophysiological measurements). During the 3 experimental days, subjects receive placebo, Lybrido or Lybridos in random order.
Subjects visit the site ŗ total of 13 times: 2 screening visits, 3 experimental days, 4 safety control visits, 3 regime follow-ups and 1 final follow up visits. During the safety control visits the subjectís health will be monitored and medication is dispensed.
|- Main changes (audit trail)|
|- RECORD||13-okt-2008 - 20-sep-2009|
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