Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 25 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | April 2010 |
| End Date: | July 2010 |
| Contact: | michael j pelekanos, md |
| Email: | mipels@aol.com |
| Phone: | 4128567500 |
The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography
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.
topically applying a cream that causes increased blood flow. This will be measured with a
sonogram.
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%,
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%,
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.
We found this trial at
1
site
Click here to add this to my saved trials
