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To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

This study has been terminated.
(poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390013
First Posted: October 19, 2006
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Colleen Stockdale, University of Iowa
  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) Drug: Gabapentin Drug: Placebo oral capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 Colleen Stockdale, University of Iowa:

Primary Outcome Measures:
  • Change From Baseline in Vulvar Pain [ Time Frame: 19 weeks ]
    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.


Enrollment: 9
Actual Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gabapentin
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
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
Placebo Comparator: Placebo oral capsule
Placebo titration and dosing for total of 8 weeks (Cross over)
Drug: Placebo oral capsule

Placebo 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: Placebo

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390013


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

Responsible Party: Colleen Stockdale, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00390013     History of Changes
Other Study ID Numbers: IRB 20060674
RR00059 ( Other Identifier: University of Iowa )
200606748 ( Other Identifier: University of Iowa )
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: March 30, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Colleen Stockdale, University of Iowa:
Vulvar Pain

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents