Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03770169
Other study ID # D-FR-52120-252
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 18, 2019
Est. completion date September 19, 2019

Study information

Verified date October 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 19, 2019
Est. primary completion date September 19, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Fluent in understanding, speaking and reading US-English

- Have vulvodynia with pain for at least 6 months

Exclusion Criteria:

- Clinically significant history of alcohol/drug abuse or dependence within the last 2 years

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Center for Vulvovaginal Disorders New York New York
United States Omaha OB-GYN Associates, PC Omaha Nebraska
United States San Diego Sexual Medicine San Diego California
United States Center for Vulvovaginal Disorders Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of mVPAQ Cognitive debrief and usability through interviews and completion of an electronic diary 1 week
Primary Validation of mFSFI Cognitive debrief and usability through interviews and completion of an electronic diary 1 week
Primary 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. 1 week
Secondary Vulvar pain NRS Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary 1 week
See also
  Status Clinical Trial Phase
Completed NCT05478746 - Effects of Flourish HEC on Localized Provoked Vulvodynia N/A
Completed NCT02404961 - Women's Health Study: Immunological Factors and Risk of Vulvodynia
Completed NCT00751010 - Relationship: Interstitial Cystitis & Vulvodynia-Part 2 N/A
Completed NCT00607490 - A Randomized Clinical Trial for Women With Vulvodynia N/A
Recruiting NCT03640624 - Multidisciplinary Treatment of Chronic Vulvar Pain N/A
Recruiting NCT05343182 - Vestibulectomy Surgical Techniques Comparison Study N/A
Recruiting NCT05518630 - An Investigation of Nomothetic Versus Idiographic Assessment in Chronic Pain
Recruiting NCT05597358 - Efficacy of High Intensity Laser for Provoked Vestibulodynia N/A
Completed NCT01304589 - Savella in Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00590590 - Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort Phase 2
Recruiting NCT06138171 - Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
Completed NCT01996384 - Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study Phase 1
Completed NCT01664962 - Search for Genetic Basis of Vulvodynia N/A
Recruiting NCT05955313 - Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia Phase 2
Completed NCT02773641 - Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Completed NCT00501774 - A Search for Helicobacter Pylori in Localized Vulvodynia N/A
Completed NCT04057755 - Botulinum Toxin A as a Treatment for Provoked Vestibulodynia Phase 3
Terminated NCT04016467 - Effect of Spinal Manipulation on Vulvar Pain N/A
Completed NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia N/A
Completed NCT02809612 - An Internet-based Information Platform for Vulvodynia Patients N/A