| October 18, 2006 |
| March 12, 2009 |
| January 2007 |
| March 2008 (final data collection date for primary outcome measure) |
| 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 ] |
| The efficacy of gabapentin to decrease vulvar pain compared to placebo will be determined at the 8 week follow up visit, by repeating all of the testing and questionnaires completed at the screening/randomization visit. |
| Complete list of historical versions of study NCT00390013 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Change in dyspareunia and burning symptom scores and change in clinical appearance and /or findings done at the screening/randomization visit will be compared to the 8 week follow up repeat questionnaires. |
| |
| To Evaluate if the Medication Gabapentin Lessens Vulvar Pain |
| Vulvar Pain: Treatment Trial Using Gabapentin-Placebo in a Cross-Over Design, Pilot Study. |
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience. |
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. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
- Vulvar Pain Symptoms
- Vulvodynia (Chronic Vulvar Pain)
- Vulvar Vestibulitis Syndrome (Chronic Vulvar Pain Localized to the Vaginal Opening)
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| Drug: Gabapentin |
| |
| |
| |
| Completed |
| 40 |
| March 2008 |
| March 2008 (final data collection date for primary outcome measure) |
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).
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| Female |
| 18 Years to 80 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00390013 |
| Colleen M. Kennedy, M.D., M.S., University of Iowa |
| 243-3225-53540306 Kennedy GCRC, RR00059, 200606748 |
| University of Iowa |
|
| Principal Investigator: |
Colleen M. Kennedy, M.D., M.S. |
University of Iowa Hospital and Clinics, Department of Ob/Gyn |
|
|
| University of Iowa |
| March 2009 |
