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To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

NCT00390013 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-07-31

Study results available
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Summary

The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

Conditions

  • Vulvar Pain Symptoms
  • Vulvodynia (Chronic Vulvar Pain)

Interventions

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.

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.

Sponsors & Collaborators

  • Colleen Stockdale

    lead OTHER

Principal Investigators

  • Colleen Kennedy Stockdale, M.D., M.S. · University of Iowa Hospital and Clinics, Department of Ob/Gyn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00390013 on ClinicalTrials.gov