Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow

Study Overview
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Brief Summary
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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.

Detailed Description
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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%,

Official Title
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The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography

Conditions
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Female Sexual Dysfunction

Intervention / Treatment
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* Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%
* Drug: Topical study cream
* Drug: GRAS cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy sexually active females ages 25-60 years Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GRAS ingredients cream<br>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. | Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%<br>* 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. With both GRAS cream and placebo.<br>* Other names: Temptation tc;Drug: GRAS cream<br>* 1 gram of active cream will be applied by nurse then 10 minutes later clitoral blood flow will be assessed by doppler studies see protocol<br>* Other names: Temptation tc;|
| Placebo Comparator: placebo cream then doppler study<br> | Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%<br>* 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. With both GRAS cream and placebo.<br>* Other names: Temptation tc;Drug: Topical study cream<br>* One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow<br>* Other names: Temptation tc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the effect study cream has on clitoral blood flow | the blood flow analysis will be measured with doppler flow plethysmography | ten minutes after application of active or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the effect study cream has on uterine blood flow | see previous description | measuring uterine flow with doppler 10 minutes after application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quantitative assessment of the effects of a topically, applied vasodilating cream to the clitoris using doppler, flow plethysmography