To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

Detailed Description
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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.

Official Title
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Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study.

Conditions
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Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) | Drug: Gabapentin<br>* 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.<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo oral capsule<br>Placebo titration and dosing for total of 8 weeks (Cross over) | Drug: Placebo oral capsule<br>* Placebo 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Vulvar Pain | change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain. | 19 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar Pain