The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to determine the effect study cream has on clitoral blood flow
研究概览
简要总结
The purpose of this study is to determine if blood flow to the clitoris is increased by topically applying a cream that causes increased blood flow. This will be measured with a sonogram.
详细描述
On the first office visit the patient will have their baseline clitoral and uterine blood flow measured quantitatively by the same sonographer using the General electric Voluson 700 unit. Clitoral blood flow will be accessed utilizing the 12 megahertz linear probe. With light pressure, the probe will be applied sagittally and proximal to the clitoral hood with an angle less than 20 degrees. Peak clitoral artery systolic and end diastolic velocity will be measured and resistive index values will be recorded. Then utilizing the 7.5 megahertz vaginal probe baseline uterine artery flow measurements will also be obtained and recorded.
The patient will then be placed in an exam room and the same nurse practitioner will apply the GRAS cream or the placebo to the patients' clitoral hood with minimal manipulation. Ten minutes later the sonographer will repeat the two scans and record the same measurements as before. The patient will then come back another day to repeat the above process. Patients will be coded to assure that which ever cream they received the first visit they will get the opposite the second time. The creams will be blinded to the nurse practitioner, the patient, the sonographer, and the principle investigator.
GRAS cream is arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy sexually active females ages 25-60 years
排除标准
- •Not eligible if they are experiencing sexual pain disorders
- •Psychological sexual aversion disorders
- •Vaginismus
- •Pregnant/nursing
- •Diabetes mellitus
- •Central nervous system disorders
- •Psychosis
- •Currently on any SSRI's, or any other condition that may effect the patient from reliably signing the informed consent.
研究组 & 干预措施
GRAS ingredients cream
The study will be placebo controlled double blind study which will require two office visits after informed consent and sensitivity testing done with the study cream on the day of recruitment.
On the first office visit the patient will have their baseline clitoral and uterine blood flow measured quantitatively by the same sonographer using the General electric Voluson 700 unit Then placebo or active cream will be applied and the pt restudied. the same process is repeated another day with the second arm cream.
干预措施: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50% (Drug)
GRAS ingredients cream
The study will be placebo controlled double blind study which will require two office visits after informed consent and sensitivity testing done with the study cream on the day of recruitment.
On the first office visit the patient will have their baseline clitoral and uterine blood flow measured quantitatively by the same sonographer using the General electric Voluson 700 unit Then placebo or active cream will be applied and the pt restudied. the same process is repeated another day with the second arm cream.
干预措施: GRAS cream (Drug)
placebo cream then doppler study
干预措施: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50% (Drug)
placebo cream then doppler study
干预措施: Topical study cream (Drug)
结局指标
主要结局
to determine the effect study cream has on clitoral blood flow
时间窗: ten minutes after application of active or placebo
the blood flow analysis will be measured with doppler flow plethysmography
次要结局
- to determine the effect study cream has on uterine blood flow(measuring uterine flow with doppler 10 minutes after application)