NCT00443248已完成1 期
A 2-Way Repeatability Study To Investigate Vaginal Blood Flow Before, During And After Visual Sexual Stimulation In Pre- And Post-Menopausal Women With And Without Female Sexual Arousal Disorder, Using The Heat Wash-Out Technique.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- To assess the safety and toleration of the heat washout device.
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 are 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 the technique's ability to differentiate between pre- and post-menopausal women; with and without Female Sexual Arousal Disorder (FSAD).
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal women aged 18-40 (with and without FSAD) or
- •Post-menopausal women aged 50-65 (with and without FSAD.
- •FSAD must have been present for at least 6 months.
排除标准
- •Pregnant or lactating women (pre-menopausal population)
- •Systemic Hormone Replacement Therapy (HRT) or Selective Estrogen Receptor Modulator (SERM) (postmenopausal population)
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.
结局指标
主要结局
To assess the safety and toleration of the heat washout device.
时间窗: 2 weeks
To investigate differences in vaginal blood flow following visual sexual stimulation in pre-menopausal women with and without FSAD.
时间窗: 2 weeks
次要结局
- To investigate changes in subjective acute sexual arousal following visual sexual stimulation in women with and without FSAD.(2 weeks)
研究者
研究点 (3)
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