A study to evaluate the different levels of attention and VALence direction for erotic stimuli, in relation to genital and subjective sexual arousal in healthy female subjects and healthy female subjects with female sexual dysfunctio

Completed

• Conditions: Female sexual dysfunction; Mental and Behavioural Disorders

• Registration Number: ISRCTN74137878
• Lead Sponsor: Emotional Brain B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

40 Subjects must meet the following criteria:
1. Subjects must have a heterosexual orientation
2. Subjects must be between 21 and 65 years of age
3. Subjects with normal sexual functioning
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, gynaecological examination, medical history, vital signs, pregnancy test and Electrocardiogram (ECG)

80 Subjects must meet the following criteria:
1. Subjects must have a heterosexual orientation
2. Subjects must be between 21 and 65 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 Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (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, gynaecological examination, medical history, vital signs, pregnancy test and ECG, and by the scoring on the strooptask during familiarization trial

Exclusion Criteria

Subjects 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 oestrogen 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 six months
6. Previous prolapse and incontinence surgery affecting the vaginal wall
7. Women with other unexplained gynaecological 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 or current psychiatric treatment
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 six months
13. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate greater than 100 bpm), or other significant abnormality observed on Electrocardiogram (ECG)
14. Systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg. For subjects with age greater than 60 years and without diabetic mellitus, familiar hypercholesterolemia or cardiovascular disease: systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 90 mmHg (according to the CBO-guideline hypertension [CBO.2000a])
15. Subjects who are taking strong CYP3A4-inhibitors: ritonavir (Human Immunodeficiency Virus [HIV] Protease inhibitor), ketoconazole and itraconazole
16. Subjects who are taking less strong CYP3A4-inhibitors: clarithromycin, erythromycine and saquinavir
17. Subjects who are taking CYP3A4-inducers: carbamazepine, phenytoin, phenobarbital, 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 and nutrition containing grapefruit
20. Subjects who are taking nitrates or nitric oxide donors
21. 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 subject's participation in the study; mild or moderately alcohol drinking behaviour 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
22. Use of any treatment for FSD within the seven days before visit one or during the study, including oral medications or constrictive devices
23. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires
24. Any 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
25. Mod

Study & Design

• Study Type: Interventional
• Study Design: Not specified