To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

Not Applicable

Terminated

• Conditions: Vulvar Pain Symptoms; Vulvodynia (Chronic Vulvar Pain)
• Interventions: Drug: Placebo oral capsule; Drug: Gabapentin

• Registration Number: NCT00390013
• Lead Sponsor: Colleen Stockdale

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 Timeline

• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Start: 2007-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2017-03-30
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-28
• Last Update Submitted: 2017-07-28
• Results First Posted: 2017-07-31
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo oral capsule	Placebo titration and dosing for total of 8 weeks (Cross over)
Gabapentin	Gabapentin	Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Vulvar Pain	19 weeks	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.

Trial Locations

Locations (1)

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States