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.
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
- 2
- 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.
研究组 & 干预措施
Vaginal Heat Wash-Out Device
干预措施: Vaginal Heat Wash-Out Device (Device)
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)