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Sponsored by: |
University of Iowa |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00390013 |
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
Condition | Intervention |
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Vulvar Pain Symptoms Vulvodynia (Chronic Vulvar Pain) Vulvar Vestibulitis Syndrome (Chronic Vulvar Pain Localized to the Vaginal Opening) |
Drug: Gabapentin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Vulvar Pain: Treatment Trial Using Gabapentin-Placebo in a Cross-Over Design, Pilot Study. |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Iowa | |
University of Iowa Hospital and Clinics | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Colleen M. Kennedy, M.D., M.S. | University of Iowa Hospital and Clinics, Department of Ob/Gyn |
Responsible Party: | University of Iowa ( Colleen M. Kennedy, M.D., M.S. ) |
Study ID Numbers: | 243-3225-53540306 Kennedy GCRC, RR00059, 200606748 |
Study First Received: | October 18, 2006 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00390013 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vulvar Pain |
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Pain Cardiovascular Agents Antimanic Agents |
Genital Diseases, Female Calcium, Dietary Vulvar Vestibulitis Anti-Anxiety Agents Vulvar Vestibulitis Syndrome Analgesics Peripheral Nervous System Agents Vulvar Diseases Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Genital Diseases, Female Membrane Transport Modulators Sensory System Agents Vulvar Vestibulitis Therapeutic Uses |
Analgesics Vulvitis Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Vulvar Diseases Anticonvulsants |