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A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

NCT01301001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2017-11-08

Study results available
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Summary

The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.

Conditions

  • Vulvodynia

Interventions

DRUG

Placebo oral capsule

Placebo 2 capsules am and 3 capsules pm

DRUG

Gabapentin

Gabapentin 1200 mg am and 1800 mg pm

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Candace S Brown, MSN, PharmD · University of Tennessee

  • David C Foster, M.D. · University of Rochester

  • Gloria A Bachmann, M.D. · Rutgers Robert Wood Johnson Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT01301001 on ClinicalTrials.gov