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

Sponsor

East Suburban Ob Gyn (Other)

Overall Status

Unknown status

CT.gov ID

NCT01085981

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Female Sexual Dysfunction	Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50% Drug: Topical study cream Drug: GRAS cream	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

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%

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%

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

Outcome Measures

Primary Outcome Measures

to determine the effect study cream has on clitoral blood flow [ten minutes after application of active or placebo]
the blood flow analysis will be measured with doppler flow plethysmography

Secondary Outcome Measures

to determine the effect study cream has on uterine blood flow [measuring uterine flow with doppler 10 minutes after application]
see previous description

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.