NCT00443027已完成1 期
Effect Of Menstrual Cycle On Vaginal Blood Flow (As Determined By The Heat Wash-Out Technique) Before, During And After Visual Sexual Stimulation In Pre-Menopausal Healthy Women.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
研究概览
简要总结
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data is collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
详细描述
Medical Device Development
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
- •Subjects must be void of Female Sexual Disorder.
排除标准
- •Pregnant or lactating women
- •Postmenopausal subjects
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.
结局指标
主要结局
To investigate differences in vaginal blood flow across the menstrual cycle following visual sexual stimulation.
时间窗: 28d
To assess the safety and toleration of the heat washout device.
时间窗: 28d
次要结局
- To investigate changes in subjective acute sexual arousal following visual sexual stimulation across the menstrual cycle.(28d)
研究者
研究点 (3)
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