Clinical trial NCT01085981: Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
Official title: The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: quantitative assessment of the effects of a topically
applied vasodilating cream to the clitoris using doppler
flow plethysmography
Lead sponsor: East Suburban Ob Gyn
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: to determine the effect study cream has on clitoral blood flow
timeFrame: ten minutes after application of active or placebo
Secondary outcomes:
measure: to determine the effect study cream has on uterine blood flow
timeFrame: measuring uterine flow with doppler 10 minutes after application
Other outcomes:
Locations:
city: Monroeville
country: United States
facility: East Suburban Obgyn
state: Pennsylvania
Study officials:
affiliation: east suburban obgyn
name: michael j pelekanos, md
role: PRINCIPAL_INVESTIGATOR
References: