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NIH Funds New Clinical Trial
The Eunice Kennedy Shriver National Institute of Child Health and Human Development has awarded its first vulvodynia research grant of the year to Drs. Candace Brown, David Foster and Gloria Bachmann, who will investigate the effectiveness of oral gabapentin in reducing the painful symptoms of Provoked Vestibulodynia (PVD, aka vulvar vestibulitis syndrome). Although gabapentin was originally indicated for the treatment of epilepsy, studies have shown that it can reduce the severity and constancy of neuropathic pain, muscle spasm and anxiety.
This 16-week, randomized, double-blind, placebo-controlled, crossover study of 120 women aims to determine if PVD patients experience less vestibular pain with tampon insertion and during intercourse when treated with gabapentin (up to 3600mg/day) compared to placebo (sugar pill). Each study participant will serve as her own control, meaning that she will take gabapentin first, followed by a wash-out period, and then placebo (or vice versa). The study also aims to identify predictors of treatment success and differentiate PVD subtypes caused or maintained by different underlying mechanisms. These include abnormalities in central nervous system pain processing, pelvic floor muscle dysfunction and dysregulation of the autonomic nervous system, which controls involuntary functions such as heart rate and digestion. The researchers' long-term goal is to determine the underlying pathophysiologic mechanisms of PVD, use this knowledge to develop evidence-based differential diagnoses of PVD subtypes and then individualize treatment for each subtype.
The three enrollment sites are located in Rochester, New York; New Brunswick, New Jersey; and Memphis, Tennessee. To learn more about the study, or to participate, visit http://clinicaltrials.gov/ct2/show/NCT01301001?term=vulvodynia&rank=7, or contact study coordinator Leslie Rawlinson at firstname.lastname@example.org or 901-682-9222.
About the Investigators
Candace Brown, PharmD, MSN, is a Professor in the Departments of Pharmacy, Obstetrics and Gynecology, and Psychiatry at the University of Tennessee Health Sciences Center in Memphis. She serves as Director of Sexual Medicine and Wellness at Women's Health Specialists, a private practice in Memphis. Her areas of research interest include chronic pain and sexual disorders in women. She holds a M.S. in psychology, a M.S.N. in nursing, and a doctorate in pharmacy. Dr. Brown completed a pharmacy residency, a postdoctoral fellowship in psychopharmacology and a sabbatical at Robert Wood Johnson Medical School. She has been the principal investigator of 60 clinical trials, presented at over 150 professional meetings and has over 165 peer-reviewed publications.
David Foster, MD, MPH, is a Professor in the Department of Obstetrics and Gynecology at the University of Rochester, and directs the Colposcopy and Vulvovaginal Disease Unit as Strong Memorial Hospital. In addition to serving as a longtime member of NVA's Medical-Scientific Advisory Board, Dr. Foster is an active member of the International Society for the Study of Vulvovaginal Disease. He received his medical degree from the Thomas Jefferson University in 1976 and completed his residency in obstetrics and gynecology at the Johns Hopkins Hospital. He also completed a fellowship in gynecologic pathology and a masters in public health in epidemiology at Johns Hopkins. Dr. Foster has conducted numerous vulvar disease research projects, and also served as principal investigator of the first vulvodynia-specific NIH-funded clinical trial, which investigated the effectiveness of oral desipramine and topical lidocaine in the treatment of Provoked Vestibulodynia.
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The National Vulvodynia Association is a nonprofit organization that strives to improve women's lives through education, support, advocacy and research funding. The NVA is not a medical authority and strongly recommends that you consult your own health care provider regarding any course of treatment or medication.