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| Sponsor: | University of Iowa |
|---|---|
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00390013 |
Purpose
The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.
| Condition | Intervention |
|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Colleen M. Kennedy, M.D., M.S., University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00390013 History of Changes |
| Other Study ID Numbers: | 243-3225-53540306 Kennedy GCRC, RR00059, 200606748 |
| Study First Received: | October 18, 2006 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Vulvar Pain |
|
Vulvar Vestibulitis Vulvodynia Vulvitis Vulvar Diseases Genital Diseases, Female Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |