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

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

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.

Study Overview

• Status: Unknown
• Conditions: Female Sexual Dysfunction
• Intervention / Treatment: Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%; Drug: GRAS cream; Drug: Topical study cream

Detailed Description

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%,

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15668
      • East Suburban Obgyn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%; 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.; Other Names: Temptation tc; Drug: GRAS cream; 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; Other Names: Temptation tc
Placebo Comparator: placebo cream then doppler study	Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%; 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.; Other Names: Temptation tc; Drug: Topical study cream; One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow; Other Names: Temptation tc

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: East Suburban Ob Gyn
• Investigators: Principal Investigator: michael j pelekanos, md, East Suburban Obgyn

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 12, 2010

Study Record Updates

• Last Update Posted (Estimate): March 12, 2010
• Last Update Submitted That Met QC Criteria: March 11, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: quantitative assessment of the effects of a topically; applied vasodilating cream to the clitoris using doppler; flow plethysmography
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 10-006