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

East Suburban Ob Gyn

Status: Unknown

Conditions: Female Sexual Dysfunction

Treatments: Drug: GRAS cream; Drug: Topical study cream; Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%

Study type: Interventional

Funder types: Other

Identifiers

NCT01085981

10-006

Details and patient eligibility

About

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.

Full 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%,

Enrollment: 30 estimated patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

GRAS ingredients cream

Active Comparator group

Description:

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.

Treatment:

Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%

Drug: GRAS cream

placebo cream then doppler study

Placebo Comparator group

Treatment:

Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%

Drug: Topical study cream