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
干预措施
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
- 2
- 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.
研究组 & 干预措施
Vaginal Heat Wash-Out Device
Experimental
干预措施: Vaginal Heat Wash-Out Device (Device)
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 (2)
Loading locations...
相似试验
已完成
1 期
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).Sexual Dysfunction, PhysiologicalNCT00443248Pfizer64
已完成
不适用
The Clinical and Biochemical Characteristics in Women With Different Menstrual PatternIrregular Menstrual CycleRegular Menstrual CycleNCT01604603Taipei Medical University WanFang Hospital470
已完成
不适用
Women and Women's Hygienic Protection: Evaluation of Women's Practices, Knowledge and Expectations for Intimate Protection.Intimate ProtectionsNCT04580719CHU de Reims1,153
已完成
不适用
Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patientsbreast cancerJPRN-UMIN000023112Hamamatsu Medical Center, Division of Pharmacy100
招募中
不适用
Getting Under the Skin of the Menopausal Hot FlushMenopauseNCT06222073Liverpool John Moores University36