Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow - Full Text View

Purpose

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	Intervention
Female Sexual Dysfunction	Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50% Drug: Topical study cream Drug: GRAS cream

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Niacin Arginine Niacinamide

U.S. FDA Resources

Further study details as provided by East Suburban Ob Gyn:

Primary Outcome Measures:

to determine the effect study cream has on clitoral blood flow [ Time Frame: ten minutes after application of active or placebo ] [ Designated as safety issue: No ]
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 [ Time Frame: measuring uterine flow with doppler 10 minutes after application ] [ Designated as safety issue: No ]
see previous description

Estimated Enrollment:	30
Study Start Date:	April 2010
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Temptation tc Drug: Topical study cream One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow Other Name: Temptation tc

Arms

Assigned Interventions

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 Name: 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 Name: 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 Name: Temptation tc

Drug: Topical study cream

One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow

Other Name: Temptation tc

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%,

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085981

Contacts

Contact: michael j pelekanos, md

4128567500

mipels@aol.com

Locations

United States, Pennsylvania
East Suburban Obgyn	Not yet recruiting
Monroeville, Pennsylvania, United States, 15668
Contact: michae j pelekanos, md 412-856-7500 mipel@aol.com
Contact: vickie lathom 4128567500 vlathom@wpahs.org

Sponsors and Collaborators

East Suburban Ob Gyn

Investigators

Principal Investigator:

michael j pelekanos, md

east suburban obgyn

More Information

No publications provided

Responsible Party:	michael pelekanos md, East suburban OBGYN
ClinicalTrials.gov Identifier:	NCT01085981 History of Changes
Other Study ID Numbers:	10-006
Study First Received:	March 2, 2010
Last Updated:	March 11, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by East Suburban Ob Gyn:

quantitative assessment of the effects of a topically
applied vasodilating cream to the clitoris using doppler
flow plethysmography

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on June 18, 2013