CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Placebo oral capsule +1 moredrug
Likely dose
Gabapentin 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01301001
NCT01301001N/ACompleted
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A Controlled Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

University of Tennessee·interventional·Posted Feb 23, 2011·Updated Nov 8, 2017

In Brief

A clinical study evaluating Placebo oral capsule and Gabapentin for Vulvodynia. Completed, enrolled 230 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvodynia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2011
Enrollment StartAug 1, 2012
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.4 years ago

Interventions

Placebo oral capsuledrug

Placebo 2 capsules am and 3 capsules pm

Gabapentindrug

Gabapentin 1200 mg am and 1800 mg pm