Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
NCT ID: NCT01085981
Last Updated: 2010-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2010-04-30
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Impact of a Topical Vasodilating Cream on Female Sexual Experience
NCT01078077
Vaginal Injection of Platelet Rich Plasma for Sexual Function
NCT05769283
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
NCT03682601
Evaluation of Gynecological Acceptability of a Health Care Product
NCT04247022
Vaginal Hyaluronic Acid, Arginine and Liposome Gel Versus Vaginal Lubricant in Postmenopausal Women With Genitourinary Syndrome of Menopause
NCT06176820
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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%,
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
placebo cream then doppler study
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.
Topical study cream
One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Topical study cream
One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
25 Years
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
East Suburban Ob Gyn
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
East suburban OBGYN
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
michael j pelekanos, md
Role: PRINCIPAL_INVESTIGATOR
east suburban obgyn
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
East Suburban Obgyn
Monroeville, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.