Female Sexual Dysfunction
Conditions
Keywords
quantitative assessment of the effects of a topically, applied vasodilating cream to the clitoris using doppler, flow plethysmography
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%,
Interventions
DRUGarginine 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.
DRUGTopical study cream
One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
DRUGGRAS 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
Sponsors
East Suburban Ob Gyn
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| to determine the effect study cream has on uterine blood flow | measuring uterine flow with doppler 10 minutes after application | see previous description |
Countries
United States
Contacts
Primary Contactmichael j pelekanos, md
Outcome results
None listed