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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by East Suburban Ob Gyn.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
East Suburban Ob Gyn
ClinicalTrials.gov Identifier:
NCT01085981
First received: March 2, 2010
Last updated: March 11, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Female Sexual Dysfunction
Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%
Drug: Topical study cream
Drug: GRAS cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography

Resource links provided by NLM:


Further study details as provided by East Suburban Ob Gyn:

Primary Outcome Measures:
  • to determine the effect study cream has on clitoral blood flow [ Time Frame: ten minutes after application of active or placebo ] [ Designated as safety issue: No ]
    the blood flow analysis will be measured with doppler flow plethysmography


Secondary Outcome Measures:
  • to determine the effect study cream has on uterine blood flow [ Time Frame: measuring uterine flow with doppler 10 minutes after application ] [ Designated as safety issue: No ]
    see previous description


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GRAS ingredients cream

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%
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.
Other Name: Temptation tc
Drug: GRAS 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
Other Name: Temptation tc
Placebo Comparator: placebo cream then doppler study Drug: arginine 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.
Other Name: Temptation tc
Drug: Topical study cream
One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
Other Name: Temptation tc

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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085981

Contacts
Contact: michael j pelekanos, md 4128567500 mipels@aol.com

Locations
United States, Pennsylvania
East Suburban Obgyn Not yet recruiting
Monroeville, Pennsylvania, United States, 15668
Contact: michae j pelekanos, md    412-856-7500    mipel@aol.com   
Contact: vickie lathom    4128567500    vlathom@wpahs.org   
Sponsors and Collaborators
East Suburban Ob Gyn
Investigators
Principal Investigator: michael j pelekanos, md east suburban obgyn
  More Information

No publications provided

Responsible Party: michael pelekanos md, East suburban OBGYN
ClinicalTrials.gov Identifier: NCT01085981     History of Changes
Other Study ID Numbers: 10-006
Study First Received: March 2, 2010
Last Updated: March 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by East Suburban Ob Gyn:
quantitative assessment of the effects of a topically
applied vasodilating cream to the clitoris using doppler
flow plethysmography

ClinicalTrials.gov processed this record on November 20, 2014