CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
Amitriptyline +6 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/NCT02099006
NCT02099006Phase 3Completed
CompareCT.gov

Novel Topical Therapies for the Treatment of Genital Pain

University of Rochester·interventional·Posted Mar 28, 2014·Updated Jul 15, 2016

In Brief

A Phase 3 clinical trial evaluating Amitriptyline, Baclofen, and 5 other interventions for Female Genital Diseases. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This study is testing drugs not previously used topically for the treatment of vulvodynia, a common genital pain syndrome. It is hoped that one of these drugs will improve vaginal entryway pain with touch, daily pain scores and sexual functioning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemale Genital Diseases
CountriesUnited States
CollaboratorsMae Stone Goode Foundation

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 28, 2014
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.3 years ago

Interventions

Amitriptylinedrug

Topical application of the drug at a 2% concentration in combination with 2% Baclofen

Baclofendrug

Used topically at 2% concentration in combination with 2% amitriptyline

Ketoprofendrug

To be applied topically at a 10% concentration

Ketaminedrug

To be applied topically at a 10% concentration

Loperamidedrug

To be applied topically at a 5% concentration

Gabapentindrug

To be applied topically at a 6% concentration

placebodrug

Compounding base to be used alone as a placebo