Pregabalin for the Treatment of Vulvodynia

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Clinical Trial Description

Vulvodynia is a condition exclusive to women and involves mostly burning, rawness, and itching of the external genitourinary tract that often results in painful intercourse. Vulvodynia rarely results in severe morbidity or mortality; rather it causes symptoms of the lower genital, urinary, and gastrointestinal tracts that can impact a woman's daily activities and negatively affect her quality of life. Despite the fact that chronic vulvovaginal symptoms are one of the most common reasons for visits to a gynecology clinic, epidemiologic studies of the incidence and prevalence of these conditions are rare and available population-based studies are limited. Approximately 16% of women will experience chronic vulvar pain at some point in their lifetime; with 5% experiencing this condition before age 25. Treatment approaches include behavioral changes, medical management, and surgery, specifically vulvar vestibulectomy. Prior to considering surgical intervention, all medical treatment options should be exhausted. Although vulvodynia is quite prevalent and can be a debilitating disease, there are few studies that critically evaluate the medical management of vulvodynia. Pregabalin is an anticonvulsant that has proven efficacy in the treatment of diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Anecdotal data and one case report provide hope that this medication may also be effective in the treatment of vulvodynia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00853229
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Terminated
Phase	Phase 2
Start date	February 2009
Completion date	April 2013

View Details

See also
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