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2007年8月23日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Female sexual dysfunction
- 发起方
- Emotional Brain B.V. (The Netherlands)
- 入组人数
- 120
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
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
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
结局指标
主要结局
未指定
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