VulvodyniaNCT03770169
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
An observational study of Vulvodynia, run by Ipsen at 4 sites in United States.
Trial summary
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vulvodynia
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2019to 19 Sep 2019
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects referred by clinicians
Who may be able to join
- Fluent in understanding, speaking and reading US-English
- Have vulvodynia with pain for at least 6 months
Who cannot join
- Clinically significant history of alcohol/drug abuse or dependence within the last 2 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Center for Vulvovaginal Disorders
New York, New York, 10036
Omaha OB-GYN Associates, PC
Omaha, Nebraska, 68130
San Diego Sexual Medicine
San Diego, California, 92120
Center for Vulvovaginal Disorders
Washington D.C., District of Columbia, 20037
About this study
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia
- Conditions
- Vulvodynia
- Medical subject headings
- Vulvodynia
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of mVPAQ
Cognitive debrief and usability through interviews and completion of an electronic diary
Measured: 1 week
Validation of mFSFI
Cognitive debrief and usability through interviews and completion of an electronic diary
Measured: 1 week
Validation of Pain on Intercourse Numeric Rating Scale (NRS)
Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.
Measured: 1 week
Secondary outcomes (1)
Vulvar pain NRS
Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start18 Feb 2019
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770169
- Sponsor's protocol ID
- D-FR-52120-252
- Status last verified
- Oct 2019
- First submitted
- 29 Nov 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Patient Reported Outcome Measures for Use in Vulvodynia
- ClinicalTrials.gov ID
- NCT03770169
- Acronym / sponsor ID
- D-FR-52120-252
- Conditions
- Vulvodynia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- 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 overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects referred by clinicians
Key inclusion criteria (2 listed)
- Fluent in understanding, speaking and reading US-English
- Have vulvodynia with pain for at least 6 months
Key exclusion criteria (1 listed)
- Clinically significant history of alcohol/drug abuse or dependence within the last 2 years
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
Validation of mVPAQ
Time frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of mFSFI
Time frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
Validation of Pain on Intercourse Numeric Rating Scale (NRS)
Time frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.
1 secondary outcome
Vulvar pain NRS
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
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Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
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.
Ipsen Medical Director study director
Ipsen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia, run by Ipsen at 4 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 2 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: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of mVPAQ (time frame: 1 week). The study lists 3 primary outcomes in all. 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 28 Oct 2019.