Pilot Interventional Study on Clitoral Ultrasound Measures and Psychobiological Correlates of Female Sexual Function
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clitoral artery peak systolic velocity and acceleration
研究概览
简要总结
Monocentric pilot interventional study. The aim of the study is to assess clitoral doppler ultrasonographic parameters in a population of sexually healthy volunteer women in order to obtain reference values. Psychobiological correlates of female sexual function will also be studied through hormonal testing and psychological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •sexually healthy
- •evidence of a personally signed and dated informed consent.
排除标准
- •any uncontrolled or unstable, acute or chronic disease
- •alcohol or drugs abuse
- •sexual dysfunction
- •any overt psychiatric or psychological condition assessed through psychological evaluation and/or self-administered validated questionnaires.
研究组 & 干预措施
Sexually healthy women
20 sexually healthy volunteer women will be enrolled from subjects consulting our outpatient clinic (subjects free from sexual dysfunction). Hormonal and ultrasound parameters and self-administered questionnaires will be evaluated.
干预措施: clitoral, transvaginal and transrectal ultrasound (Other)
结局指标
主要结局
Clitoral artery peak systolic velocity and acceleration
时间窗: baseline
This will not be evaluated in different time frames but evaluated in order to assess reference values in sexually healthy women and compared with subjects with sexual dysfunction.
次要结局
- General psychopathology assessed through the Middlesex Hospital Questionnaire (MHQ)(baseline)
- Body image is investigated through the Body Uneasiness Test (BUT)(baseline)
- Female sexual function assessed through the Female Sexual Function Index (FSFI)(baseline)
- Measurement of the thickness of the urethrovaginal space(baseline)
- Measurement of the thickness of the endometrial lining(baseline)
- Hormonal parameters (17β-estradiol, total testosterone, LH, FSH, TSH, PRL, delta-4-androstenedione, DHEAS, 17-Hydroxyprogesterone, SHBG)(baseline)
- Metabolic parameters (total cholesterol, HDL, triglycerides, glycemia, insulin, glycated hemoglobin)(baseline)
研究者
Mario Maggi
Full Professor of Endocrinology
University of Florence