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

Female Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01085981
• Other study ID #: 10-006
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2010
• Last updated: March 11, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: East Suburban Ob Gyn
• Contact: michael j pelekanos, md
• Phone: 4128567500
• Email: mipels[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%,

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	East Suburban Obgyn	Monroeville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
East Suburban Ob Gyn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to determine the effect study cream has on uterine blood flow	see previous description	measuring uterine flow with doppler 10 minutes after application	No