To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Primary Purpose
Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Pain Symptoms focused on measuring Vulvar Pain
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).
Sites / Locations
- University of Iowa Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gabapentin
Placebo oral capsule
Arm Description
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Placebo titration and dosing for total of 8 weeks (Cross over)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390013
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
January 2007 (Actual)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Colleen Stockdale
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Pain Symptoms, Vulvodynia (Chronic Vulvar Pain)
Keywords
Vulvar Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
Placebo titration and dosing for total of 8 weeks (Cross over)
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Vulvar Pain
Description
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.
Time Frame
19 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Kennedy Stockdale, M.D., M.S.
Organizational Affiliation
University of Iowa Hospital and Clinics, Department of Ob/Gyn
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
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