A double blind randomized placebo controlled cross-over study to validate the distinction between women with different levels of attention and valence direction for erotic stimuli, in relation with genital and subjective sexual arousal in healthy female subjects and healthy female subjects with FSD. - VA
- Conditions
- Hypoactive sexual desire disorder and female sexual arousal disorder
- Registration Number
- EUCTR2007-002009-31-NL
- Lead Sponsor
- Emotional Brain BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1Subjects must have a heterosexual orientation or secondary bisexual orientation
2Subjects must be between 21 and 65 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 a, but not limited to, physical examination (including a gynecological examination), medical history, vital signs, pregnancy test and ECG, and by the scoring on the strooptask 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) no
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;
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 neurological treatment or current neurological treatment;
10History of serious psychiatric treatment or current psychiatric treatment;
11Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
12History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
13Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG;
14Systolic 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)).
15Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol
16Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir
17Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine
18Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;
19Use of medicinal herb as Ginkgo Biloba and nutrition containing grapefruit;
20Subjects who are taking nitrates or nitric oxide donors;
21A 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.
22Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices;
23Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
24Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s 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;
25Moderate and severe hearing impairment;
26Subjects who are colour blinded.
27Subjects who are having botox® (or other equivalents of botox, like dysport) in the facial area within 6 months before the first experimental da
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method