To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Information source: University of Iowa
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvar Pain Symptoms; Vulvodynia (Chronic Vulvar Pain); Vulvar Vestibulitis Syndrome (Chronic Vulvar Pain Localized to the Vaginal Opening)
Intervention: Gabapentin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
Colleen M. Kennedy, M.D., M.S., Principal Investigator, Affiliation: University of Iowa Hospital and Clinics, Department of Ob/Gyn
Summary
The purpose of this research study is to evaluate if the medication gabapentin lessens the
vulvar pain some women experience.
Clinical Details
Official title: Vulvar Pain: Treatment Trial Using Gabapentin-Placebo in a Cross-Over Design, Pilot Study.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
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).
Locations and Contacts
University of Iowa Hospital and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Regina R. Arthur, ADN, Phone: 319-384-8028, Email: regina-arthur@uiowa.edu
Denise Haury, BSN, Phone: 319-384-7344, Email: denise-haury@uiowa.edu
Colleen M. Kennedy, M.D., M.S., Principal Investigator
Additional Information
Starting date: January 2007
Ending date: December 2008
Last updated: December 4, 2008
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