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

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ClinicalTrials.gov Identifier: NCT01085981
Recruitment Status : Unknown
Verified March 2010 by East Suburban Ob Gyn.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2010
Last Update Posted : March 12, 2010
Sponsor:
Information provided by:
East Suburban Ob Gyn

Tracking Information
First Submitted Date  ICMJE March 2, 2010
First Posted Date  ICMJE March 12, 2010
Last Update Posted Date March 12, 2010
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
to determine the effect study cream has on clitoral blood flow [ Time Frame: ten minutes after application of active or placebo ]
the blood flow analysis will be measured with doppler flow plethysmography
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
to determine the effect study cream has on uterine blood flow [ Time Frame: measuring uterine flow with doppler 10 minutes after application ]
see previous description
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
Official Title  ICMJE The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic 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%,

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Female Sexual Dysfunction
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%
    • Drug: GRAS cream
  • Placebo Comparator: placebo cream then doppler study
    Interventions:
    • Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%
    • Drug: Topical study cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 11, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085981
Other Study ID Numbers  ICMJE 10-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party michael pelekanos md, East suburban OBGYN
Study Sponsor  ICMJE East Suburban Ob Gyn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: michael j pelekanos, md east suburban obgyn
PRS Account East Suburban Ob Gyn
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP