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Vestibulodynia: UPDATe

University of North Carolina at Chapel Hill


Description

This is a research study about vestibulodynia, a condition where women feel pain at the opening of the vagina. They feel this pain regularly when there is pressure in the vagina - pressure from using tampons and/or pressure from sexual activity. Vestibulodynia is very common - it affects one out of every six women. Through this study, we hope to find out which medications work best to relieve pain from vestibulodynia, and also find out more about what is happening in the body when women have vestibulodyina.


Keywords:

Pain, Women's Health


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
18 - 50 years


Gender
Female


Study Population

Women ages 18-50 years old who self-report at least three continuous months of vaginal pain 1) with sexual contact involving penetration into the vagina, and/or 2) with touch to the vaginal opening, and/or 3) with tampon insertion.


Investigator

Elizabeth Geller
Associate Professor
Obstetrics and Gynecology-Urogynecology and Reconstructive Pelvic Surgery

For questions, contact:

Debbie Farb
debbie.farb@unc.edu
(919) 886-3024
Visit Website

Recruitment Period End

October 22, 2023

Location

Primary Location
UNC Hospitals, Hillsborough Campus
430 Waterstone Dr, Hillsborough, NC 27278, USA
Secondary Location
Each visit includes TWO locations within UNC Hospitals, Hillsborough Campus: 1) Lab/consult room on 2nd floor of hospital; 2) MIGS clinic on 3rd floor of medical office building
460 Waterstone Drive UNC Health Care Medical Office Building, Campus, Hillsborough, NC 27278, USA

Study Qualifications

Gender Female

Age Range 18 - 50 years

Participant qualification(s) Female; Ages 18-50 years old; Able to easily speak, understand, and read English; Self-report of at least three continuous months of vaginal pain 1) with sexual contact involving penetration into the vagina, and/or 2) with touch to the vaginal opening, and/or 3) with tampon insertion

Not eligible if: Will complete phone/email pre-screening before enrollment visit to review all exclusion criteria. Participants may not be pregnant, breastfeeding or planning to become pregnant during the study period. Participants also may not be post-menopausal (no menses for 12 consecutive months). There are also certain medications participants may not be taking, as well as certain medical conditions that would exclude them.

Number of Visits

    » 4 In person visit(s)

    Participants will attend four in-person visits at UNC Hospitals, Hillsborough campus over six months. Each visit is 2-3 hours long, and includes questionnaires, blood tests, physical exam and medication dispensed to take at home.

    » 1 Remote visit(s)

    If you express interest in the study, the next step is a 10-15 minute pre-screening phone call to see if you qualify for the study and to share information with you. This phone call may be completed by email instead of phone if you prefer.

Participation Period

six months

Compensation

The total compensation for the study is a $60 Visa gift card, which includes all four study visits. You will receive your compensation at your final study visit. If you do not complete all four study visits, you will receive compensation based on how many visits you do attend.

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.