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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

March 2, 2010
March 11, 2010
April 2010
June 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01085981 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
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.

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%,

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Female Sexual Dysfunction
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
July 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
25 Years to 60 Years
Yes
Contact: michael j pelekanos, md 4128567500 mipels@aol.com
United States
 
NCT01085981
10-006
No
michael pelekanos md, East suburban OBGYN
East Suburban Ob Gyn
Not Provided
Principal Investigator: michael j pelekanos, md east suburban obgyn
East Suburban Ob Gyn
March 2010

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