ybridos 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 - Lybridos PoC
- Conditions
- Female Sexual Dysfunction, specifically Hypoactive Sexual Desire Disorder, with or without Female Sexual Arousal Disorder.MedDRA version: 9.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorder
- Registration Number
- EUCTR2008-007704-28-NL
- Lead Sponsor
- Emotional Brain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 13
Thirteen (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:
1Subjects must have a heterosexual orientation.
2Subjects must be between 21 and 70 years of age.
3Subjects 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.
4Subjects must have signed the Informed Consent Form.
5Inclusion 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.
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
Subjects will not be eligible for inclusion if one of the following criteria applies:
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;
7Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
8History of endocrinological treatment or current endocrinological treatment (with the exception of the use oral contraceptives and of fertility-promoting treatment);
9History of moderate or severe neurological complaints or current moderate or severe neurological complaints and/or treatment for current moderate or severe neurological complaints;
10History of moderate or severe psychiatric complaints or current moderate or severe psychiatric complaints and/or treatment for current moderate or severe psychiatric complaints;
11History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
12Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG;
13Systolic 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
14Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol
15Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir
16Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine
17Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;
18Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression)
19Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, SSRIs, TCAs, Tramadol;
20A 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 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.
21Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices;
22Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
23Any other clinically significant abnormality or condition which in the op
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective:<br>To evaluate efficacy of Lybridos on physiological and subjective indices of sexual arousal in healthy female subjects with Female Sexual Dysfunction. <br><br>;Secondary Objective: Secondary objectives:<br>-To investigate Lybridos’ influence on attentional bias for erotic stimuli.<br>-To evaluate the safety of Lybridos.<br>;Primary end point(s): Primary endpoints<br>-Vaginal Pulse Amplitude (VPA)<br>-Clitoral Blood Volume (CBV)<br>-Subjective ratings of sexual functioning (questionnaires)<br>
- Secondary Outcome Measures
Name Time Method