To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
Vulvar Pain Symptoms
Vulvodynia (Chronic Vulvar Pain)
Vulvar Vestibulitis Syndrome (Chronic Vulvar Pain Localized to the Vaginal Opening)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Vulvar Pain: Treatment Trial Using Gabapentin-Placebo in a Cross-Over Design, Pilot Study.|
- The efficacy of gabapentin to decrease vulvar pain compared to placebo will be determined at the 8 and 19 week follow up visits, by reported change in vulvar pain. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
- Change in dyspareunia and burning symptom scores and change in clinical appearance and qualitative and quantitive tests performed will be compared at the 8 and 19 week follow up visits. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- day 1 you will take 1 capsule for the day
- day 2 you will take 1 capsule 2 times for that day
- days 3-6 you will take 1 capsule 3 times for those days
- days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
- days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
- days 13-14 you will take 2 capsules 3 times each day
- continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
- at completion of study treatment you will titrate off study drug over a weeks time.
300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390013
|United States, Iowa|
|University of Iowa Hospital and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Colleen M. Kennedy, M.D., M.S.||University of Iowa Hospital and Clinics, Department of Ob/Gyn|