To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Overview[ - collapse ][ - ]
| Purpose | The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience. |
|---|---|
| Condition | Vulvar Pain Symptoms Vulvodynia (Chronic Vulvar Pain) Vulvar Vestibulitis Syndrome (Chronic Vulvar Pain Localized to the Vaginal Opening) |
| Intervention | Drug: Gabapentin |
| Phase | N/A |
| Sponsor | University of Iowa |
| Responsible Party | University of Iowa |
| ClinicalTrials.gov Identifier | NCT00390013 |
| First Received | October 18, 2006 |
| Last Updated | March 12, 2009 |
| Last verified | March 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 18, 2006 |
|---|---|
| Last Updated Date | March 12, 2009 |
| Start Date | January 2007 |
| Estimated Primary Completion Date | March 2008 |
| Current Primary Outcome Measures | 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] |
| Current Secondary Outcome Measures | 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | To Evaluate if the Medication Gabapentin Lessens Vulvar Pain |
|---|---|
| Official Title | Vulvar Pain: Treatment Trial Using Gabapentin-Placebo in a Cross-Over Design, Pilot Study. |
| Brief Summary | The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience. |
| Detailed Description | 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Gabapentin 300 mg. capsules Dosage schedule for weeks 1 and 2 and weeks 12 and 13: 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. Other Names: Neurontin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | March 2008 |
| Estimated Primary Completion Date | March 2008 |
| Eligibility Criteria | Inclusion Criteria: - All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic. Exclusion Criteria: - Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4). |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00390013 |
|---|---|
| Other Study ID Numbers | 243-3225-53540306 Kennedy GCRC |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Iowa |
| Study Sponsor | University of Iowa |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Colleen M. Kennedy, M.D., M.S. University of Iowa Hospital and Clinics, Department of Ob/Gyn |
| Verification Date | March 2009 |
Locations[ + expand ][ + ]
| University of Iowa Hospital and Clinics | Iowa City, Iowa, United States, 52242 |
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