CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Topical liquid lidocaine +1 moredrug
Likely dose
Not stated in 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/NCT01539317
NCT01539317Phase 3Completed
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Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

OHSU Knight Cancer Institute·interventional·Posted Feb 27, 2012·Updated Apr 14, 2017

In Brief

A Phase 3 clinical trial evaluating Topical liquid lidocaine and Topical saline for Vulvodynia and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvodynia, Dyspareunia, Breast Cancer, Menopause
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2012
Enrollment StartDec 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.3 years ago

Interventions

Topical liquid lidocainedrug

active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule

Topical salinedrug

saline applied to the vestibule mucosa will not reverse the local tenderness