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.

Study Overview

• Status: Terminated
• Conditions: Vulvar Pain Symptoms; Vulvodynia (Chronic Vulvar Pain)
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo oral capsule

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
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin; Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)	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
Placebo Comparator: Placebo oral capsule; Placebo titration and dosing for total of 8 weeks (Cross over)	Drug: Placebo oral capsule; 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.; Other Names: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Colleen Stockdale
• Investigators: Principal Investigator: Colleen Kennedy Stockdale, M.D., M.S., University of Iowa Hospital and Clinics, Department of Ob/Gyn

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: October 18, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (Estimate): October 19, 2006

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Vulvar Pain
• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvodynia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: IRB 20060674; RR00059 (University of Iowa); 200606748 (Other Identifier: University of Iowa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No