ISRCTN74137878已完成不适用
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
Emotional Brain B.V. (The Netherlands)0 个研究点目标入组 120 人开始时间: 2007年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
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