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

NCT01085981 | Unknown

• 1 other identifier: 10-006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction

Keywords

quantitative assessment of the effects of a topically; applied vasodilating cream to the clitoris using doppler; flow plethysmography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• to determine the effect study cream has on uterine blood flow

  measuring uterine flow with doppler 10 minutes after application

Study Arms (2)

GRAS ingredients cream

ACTIVE COMPARATOR

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.

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

placebo cream then doppler study

PLACEBO COMPARATOR

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

Interventions

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

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.

Also known as: Temptation tc

GRAS ingredients cream; placebo cream then doppler study

Topical study cream DRUG

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

Also known as: Temptation tc

placebo cream then doppler study

GRAS cream DRUG

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

Also known as: Temptation tc

GRAS ingredients cream

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy sexually active females ages 25-60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Suburban Ob Gyn: lead

Study Sites (1)

East Suburban Obgyn

Monroeville, Pennsylvania, 15668, United States

Location

MeSH Terms

Interventions

Arginine; Niacinamide

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• michael j pelekanos, md

  east suburban obgyn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

michael j pelekanos, md

CONTACT

4128567500; mipels@aol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 12, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 12, 2010

Record last verified: 2010-03

Locations

US (1)