CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Milnaciprandrug
Likely dose
Milnacipran 12.5mgfrom 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/NCT01304589
NCT01304589Phase 3Completed
CompareCT.gov

An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia

University of Tennessee·interventional·Posted Feb 25, 2011·Updated Jun 11, 2018

In Brief

A Phase 3 clinical trial evaluating Milnacipran for Vestibulodynia and Vulvodynia. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVestibulodynia, Vulvodynia
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2011
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.4 years ago

Interventions

Milnaciprandrug

6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks