Candace Brown Study to Test Gabapentin as an Effective Treatment for vulvar pain in women.
Memphis, Tenn. (August 21, 2012) — Candace Brown, MSN, PharmD, professor in the Departments of Pharmacy, Obstetrics and Gynecology, and Psychiatry at the University of Tennessee Health Science Center (UTHSC), has received a $2.6 million grant to lead the first national, multicenter study of a treatment to reduce vulvar pain in women. Vulvar pain, or provoked vestibulodynia (PVD), is a condition wherein women suffer burning, irritation or rawness at the vaginal entrance during sexual intercourse, or whenever there is contact triggering the pain, such as when wearing tight pants or riding a bike. Approximately 14 million women across the United States suffer from PVD.
The $2.6 million grant was awarded to UTHSC by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the National Institutes of Health. The PVD study will continue over the next four years.
UTHSC will grant subawards to collaborators of the multicenter study and is the primary site for collecting data. The collaborators include the University of Medicine and Dentistry of New Jersey, New Brunswick, and the University of Rochester in Rochester, N.Y. Dr. Brown is the coordinator for all three study sites and the principal investigator for the study in the Memphis region. The collaborators joined forces to assemble only investigators who have successfully performed large scale randomized controlled trials on PVD treatments.
The Memphis research team also includes Frank Ling, MD, director, Center of Excellence for Pelvic Pain at Women’s Health Specialists in Germantown, Tenn.; Edwin Thorpe, MD, associate professor, UTHSC Department of Obstetrics and Gynecology; Jim Wan, PhD, associate professor, UTHSC Department of Preventive Medicine; Laura Thoma, PharmD, professor, UTHSC Department of Pharmaceutical Sciences, and Risa Ramsey, PhD, associate professor, UTHSC College of Nursing. Additional Memphis team members include Ian Brooks, PhD, and Chanchai McDonald, PhD, both from the UTHSC Office of Biomedical Informatics, who developed a custom online database for data collection across all the sites.
PVD has no known cause and no proven treatment. However, gabapentin, an anticonvulsant treatment that will be used in the national study, has appeared to be effective in previous, localized trials. The aim of the multicenter study is to prove the effectiveness of gabapentin as a treatment for PVD and to determine what causes the condition.
“Women burdened with vulvar pain are frequently reluctant to report the problem and confused about what causes it,” said Dr. Brown. “Many PVD sufferers have seen multiple doctors and receive no relief after trying several, unproven treatments. They are sometimes told ‘it’s all in your head’ and are left not knowing where to turn. Our study offers hope that gabapentin, which is widely used to treat neuropathic pain, will relieve the burning and irritation of PVD, which is the most common form of vulvar pain in pre-menopausal women.”
The scientists seek to enroll a total of 120 women for the study, 40 at each site. Participants must be between the ages of 18 and 50 and recruitment will begin in September. Participants wil be seen at the Methodist University Hospital Clinical Research Center (CRC) and at Women’s Health Specialists in Germantown.
Women participating in the research will be examined over a 16-week period. For the first eight weeks, they will be randomly selected to receive either the study treatment, gabapentin, or a placebo. During the following eight weeks, participants will alternate and take either Gabapentin or a placebo that was not taken initially. The participants will be provided a pain questionnaire used to measure changes in qualitative pain using a pain rating index. Scientists will analyze responses to the questions to determine gabapentin’s effectiveness. All treatment and medical procedures will be provided at no cost to participants, and the women will be offered a small reimbursement for travel.
Women interested in obtaining more information or participating in the study should call Michelle J. Washington, PharmD, UTHSC Department of Clinical Pharmacy, at (901) 448-1500, or via e-mail at mwashi10@uthsc.edu. Interested parties may also visit the Website for more information: https://www.hopeformypain.org.
Established by Congress in 1962, the National Institute of Child Health and Human Development conducts and supports research on topics related to the health of children, adults, families, and populations. The National Institutes of Health (NIH), the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
As the flagship statewide academic health system, the mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service. In 2011, UT Health Science Center celebrated its centennial: 100 years advancing the future of health care. Offering a broad range of postgraduate training opportunities, the main UTHSC campus is located in Memphis and includes six colleges: Allied Health Sciences, Dentistry, Graduate Health Sciences, Medicine, Nursing and Pharmacy. The UTHSC campus in Knoxville includes a College of Medicine, College of Pharmacy, and an Allied Health Sciences unit. In addition, the UTHSC Chattanooga campus includes a College of Medicine and an Allied Health Sciences unit. Since its founding in 1911, UTHSC has educated and trained more than 53,000 health care professionals on campuses and in health care facilities across the state. For more information, visit www.uthsc.edu.