To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00390013
First received: October 18, 2006
Last updated: March 12, 2009
Last verified: March 2009
  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.

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: Gabapentin

    300 mg. capsules

    Dosage schedule for weeks 1 and 2 and weeks 12 and 13:

    1. day 1 you will take 1 capsule for the day
    2. day 2 you will take 1 capsule 2 times for that day
    3. days 3-6 you will take 1 capsule 3 times for those days
    4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
    5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
    6. days 13-14 you will take 2 capsules 3 times each day
    7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
    8. at completion of study treatment you will titrate off study drug over a weeks time.
    Other Name: Neurontin
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390013

Locations
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Colleen M. Kennedy, M.D., M.S. University of Iowa Hospital and Clinics, Department of Ob/Gyn
  More Information

No publications provided

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

Keywords provided by University of Iowa:
Vulvar Pain

Additional relevant MeSH terms:
Vulvodynia
Pain
Vulvar Vestibulitis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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

ClinicalTrials.gov processed this record on August 18, 2014