Female Sexual DysfunctionTVConFSDNCT01078077
The Impact of a Topical Vasodilating Cream on Female Sexual Experience
An observational study of Female Sexual Dysfunction, run by Michael Pelekanos MD at 3 sites in United States.
Trial summary
The purpose of this study is to determine if a topical vasodilating cream will improve female sexual experience. 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
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Jul 2012
- Phase
- Observational
- 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
Study population: Sexually active females from ages 25 to sixty not on SSRI's without neurologic disease able sign and understand informed consent
Who may be able to join
- Healthy females ages 25 to sixty sexually active
Who cannot join
- Neurologic disease, on SSRI's,advanced diabetes, non sexually active, mentally incompetent
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
East Suburban Obgyn
Monroeville, Pennsylvania, 15146
Michael J Pelekanos, MD, 412-779-1034, mipels@aol.com
Guy Stoffman, MD, 412 3706313, guystof@aol.com
- Recruiting
West Penn Allegheny Health Center
Monroeville, Pennsylvania, 15146
pelekanos, 412-856-7500
vickie lathom, 4128567500
- Recruiting
West Penn Hospital Forbes Campus
Monroeville, Pennsylvania, 15146
michael j pelekanos, md, 412-856-7500, mipels@aol.com
michael j pelekanos, md
About this study
Official title: The Impact of a Topical Vasodilating Cream (When Applied to the Clitoris) on the Female Sexual Experience Using a Standard 7 Part Female Sexual Dysfunction Questionnaire
The purpose of this study is to determine if a topical vasodilating cream will improve female sexual experience.
Read the detailed description
To determine in a placebo controlled double blinded study whether a topically applied vasodilating cream will improve the female sexual response as measured by a standard female sexual dysfunction questionnaire
- Conditions
- Female Sexual Dysfunction
- Keywords
- healthy females ages twentyfive through sixty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionJul 2012 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Pelekanos MD
- Sponsor type
- University, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Responsible party
- Sponsor-investigator, Michael Pelekanos MD, East Suburban Ob Gyn
- Investigators
- michael j pelekanos, MD, Principal investigator, east surburban obgyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078077
- Sponsor's protocol ID
- 10-005
- Acronym
- TVConFSD
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2010
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Topical Vasodilating Cream (When Applied to the Clitoris) on the Female Sexual Experience Using a Standard 7 Part Female Sexual Dysfunction Questionnaire
- ClinicalTrials.gov ID
- NCT01078077
- Acronym / sponsor ID
- TVConFSD / 10-005
- Conditions
- Female Sexual Dysfunction
- Keywords
- healthy females ages twentyfive through sixty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Michael Pelekanos MDUniversity, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 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 a topical vasodilating cream will improve female sexual experience.
Detailed description
To determine in a placebo controlled double blinded study whether a topically applied vasodilating cream will improve the female sexual response as measured by a standard female sexual dysfunction questionnaire
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sexually active females from ages 25 to sixty not on SSRI's without neurologic disease able sign and understand informed consent
Key inclusion criteria (1 listed)
- Healthy females ages 25 to sixty sexually active
Key exclusion criteria (1 listed)
- Neurologic disease, on SSRI's,advanced diabetes, non sexually active, mentally incompetent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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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 surburban obgyn
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Sexual Dysfunction, run by Michael Pelekanos MD at 3 sites 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 1 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 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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.
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 2 Mar 2012.