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A double blind, randomized, cross-over placebo controlled pilot study to investigate the subjective and physiological efficacy and safety of Lybridos in healthy female subjects with Female Sexual Dysfunction.


- candidate number5183
- NTR NumberNTR1637
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2009
- Secondary IDsEB 077 Emotional Brain
- Public TitleA double blind, randomized, cross-over placebo controlled pilot study to investigate the subjective and physiological efficacy and safety of Lybridos in healthy female subjects with Female Sexual Dysfunction.
- Scientific TitleLybridos PoC:
A double blind, randomized, cross-over placebo controlled pilot study to investigate the subjective and physiological efficacy and safety of Lybridos in healthy female subjects with Female Sexual Dysfunction.
- ACRONYMLybridos PoC
- hypothesisIn the present study we will investigate the efficacy of Lybridos in one group of subjects with FSD in the laboratory. We will measure subjective, physiological and neuropsychological measures of sexual functioning in the Emotional Brain laboratory.

Hypothesis:
1. Lybridos, compared to placebo, significantly increases subjective measures of sexual arousal;
2. Lybridos, compared to placebo, significantly increases genital measures of sexual arousal;
3. Lybridos, compared to placebo, significantly increases attentional bias for sexual cues.
- Healt Condition(s) or Problem(s) studiedFemale sexual arousal disorder, Hypoactive sexual desire disorder (HSDD), Female sexual dysfunction (FSD)
- Inclusion criteriaThirteen (13) premenopausal and postmenopausal women with Hypoactive Sexual Desire Disorder (HSDD), with or without Female Sexual Arousal Disorder (FSAD).

Additionally, subjects must meet the following criteria:
1. Subjects must have a heterosexual orientation;
2. Subjects must be between 21 and 70 years of age;
3. Subjects must have experienced low sexual arousal and/or low sexual desire for at least six months prior to study entry according to DSM IV criteria. The diagnosis will be made by an experienced psychologist/sexologist;
4. Subjects must have signed the Informed Consent Form;
5. Inclusion will be following the selection criteria including, but not limited to, a physical examination, gynecological examination, medical history, vital signs, pregnancy test and ECG, and by the scoring on the Stroop task during familiarization trial.
- Exclusion criteriaSubjects will not be eligible for inclusion if one of the following criteria applies:
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);
9. 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 participantís 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;
10. History of severe psychiatric problems or current severe psychiatric problems, or other mild or moderate psychiatric problems which in the opinion of investigator would interfere with the participantís 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;
11. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
12. Renal insufficiency (< 30 ml/min): based on the Cockcroft and Gauld formula;
13. Liver insufficiency: when ASAT or ALAT > 3x normal laboratory values;
14. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG;
15. 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;
16. Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol;
17. Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir;
18. Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoÔne, fenobarbital, st Johns Wort, rifampicine;
19. Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;
20. 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);
21. Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, SSRIs, TCAs, Tramadol;
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 are experiencing vision impairment, like partial or complete blindness or color blindness;
27. Subjects with a peri menopausal hormonal status;
28. Subjects with a body mass index (BMI)>35 kg/m2.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-jan-2009
- planned closingdate1-mei-2009
- Target number of participants13
- InterventionsLybridos (one gift) and placebo (one gift).
- Primary outcomeTo evaluate efficacy of Lybridos on physiological and subjective indices of sexual arousal in healthy female subjects with Female Sexual Dysfunction.
- Secondary outcome1. To investigate Lybridosí influence on attentional bias for erotic stimuli;
2. To evaluate the safety of Lybridos.
- TimepointsIn 2 arms, a total of 13 subjects receive the investigational drug on one experimental day and receive placebo on another experimental day.
- Trial web sitewww.emotionalbrain.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. K. Rooij, van
- CONTACT for SCIENTIFIC QUERIESDrs. K. Rooij, van
- Sponsor/Initiator Emotional Brain BV
- Funding
(Source(s) of Monetary or Material Support)
Emotional Brain BV
- PublicationsN/A
- Brief summaryIn 2 arms, a total of 13 subjects receive the investigational drug. During the 2 experimental days (where psychophysiological measurements will take place), subjects receive placebo and Lybridos in random order. Subjects visit the site ŗ total of 4 times: 1 screening visit, 2 experimental days, and 1 final follow up visit.
- Main changes (audit trail)
- RECORD21-jan-2009 - 13-sep-2009


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