drugset / Trial / NCT01301001

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response

NCT01301001

Completed 230 enrolled University of Tennessee
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule 3000 mg

Indications