A chronic syndrome called vulvodynia that affects from four to seven percent of women is being studied by physicians at The Women's Health Institute at Robert Wood Johnson Medical School, part of Rutgers, The State University of New Jersey, in hopes of alleviating sometimes excruciating pain. The purpose of the study is to determine the effectiveness of gabapentin, a medication that is FDA-approved as a treatment for nerve-related pain and other conditions, when used as an extended release therapy. The study is funded by the National Institutes of Health (1R01HD065740-01A1 and 1RC1HD063902-01).
Vulvodynia is a pain that occurs on the external part of a woman's vaginal area, known as the vulva. Symptoms include constant vulvar pain or pain caused by touch from activities including prolonged sitting, exercise, sexual activity, tight-fitting clothing and other daily activities. Study applicants will receive clinical exams by physicians in the Department of Obstetrics, Gynecology and Reproductive Medicine at Rutgers Robert Wood Johnson Medical School to diagnose vulvodynia and determine eligibility for the 16-week study. Eligible participants must be female and at least 18 years old, and have ongoing vulvar pain due to activities or touch and have no other cause of pain such as from an infection. Physicians will help diagnose applicants who are ineligible for the study and refer them to an appropriate physician for treatment.
Eligible participants will receive either the study medication or a placebo (a pill, which has no treatment) for the first eight weeks. During the second eight-week period, participants will receive the opposite treatment. Medication will be provided at no charge and participants will be compensated at the completion of each of the six required clinical visits.
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