Female Sexual DysfunctionNCT01085981
Assessing the Effects of a Topically Applied Cream to Clitoral Blood Flow
A study testing arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Topical study cream and GRAS cream in people with Female Sexual Dysfunction, run by East Suburban Ob Gyn at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Topical study cream and GRAS cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy sexually active females ages 25-60 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Suburban Obgyn
Monroeville, Pennsylvania, 15668
michae j pelekanos, md, 412-856-7500, mipel@aol.com
vickie lathom, 4128567500, vlathom@wpahs.org
About this study
Official title: 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.
Read the 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%,
- Conditions
- Female Sexual Dysfunction
- Being tested
- arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Topical study cream, GRAS cream
- Keywords
- quantitative assessment of the effects of a topically, applied vasodilating cream to the clitoris using doppler, flow plethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%Drug
Also called Temptation tc
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 creamDrug
Also called Temptation tc
One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
GRAS creamDrug
Also called Temptation tc
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%; Drug: GRAS cream |
| placebo cream then doppler study | Placebo comparator | Not described Receives: Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%; Drug: Topical study cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the effect study cream has on clitoral blood flow
the blood flow analysis will be measured with doppler flow plethysmography
Measured: ten minutes after application of active or placebo
Secondary outcomes (1)
to determine the effect study cream has on uterine blood flow
see previous description
Measured: measuring uterine flow with doppler 10 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Suburban Ob Gyn
- Sponsor type
- University, hospital or other
- Investigators
- michael j pelekanos, md, Principal investigator, east suburban obgyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085981
- Sponsor's protocol ID
- 10-006
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quantitative Analysis of Clitoral Blood Before and After a Topically Applied Vasodilating Cream Using Sonographic Doppler Flow Plethysmography
- ClinicalTrials.gov ID
- NCT01085981
- Acronym / sponsor ID
- 10-006
- Conditions
- Female Sexual Dysfunction
- Keywords
- quantitative assessment of the effects of a topically, applied vasodilating cream to the clitoris using doppler, flow plethysmography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- East Suburban Ob GynUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRAS ingredients cream | Active comparator | Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Drug: GRAS creamThe 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. |
| placebo cream then doppler study | Placebo comparator | Drug: arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Drug: Topical study cream |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy sexually active females ages 25-60 years
Key exclusion criteria (8 listed)
- Not eligible if they are experiencing sexual pain disorders
- Psychological sexual aversion disorders
- Vaginismus
- Pregnant/nursing
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%Also: Temptation tcOn 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. | Drug | GRAS ingredients cream, placebo cream then doppler study |
| Topical study creamAlso: Temptation tcOne gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow | Drug | placebo cream then doppler study |
| GRAS creamAlso: Temptation tc1 gram of active cream will be applied by nurse then 10 minutes later clitoral blood flow will be assessed by doppler studies see protocol | Drug | GRAS ingredients cream |
Primary outcome
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
1 secondary outcome
to determine the effect study cream has on uterine blood flow
Time frame: measuring uterine flow with doppler 10 minutes after application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
michael j pelekanos, md principal investigator
east suburban obgyn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%, Topical study cream and GRAS cream in people with Female Sexual Dysfunction, run by East Suburban Ob Gyn at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact michael j pelekanos, md (4128567500, mipels@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the effect study cream has on clitoral blood flow (time frame: ten minutes after application of active or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2010.