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Novel Topical Therapies for the Treatment of Genital Pain

NCT02099006 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-07-15

Study results available
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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.

Conditions

  • Female Genital Diseases

Interventions

DRUG

Amitriptyline

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

DRUG

Baclofen

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

DRUG

Ketoprofen

To be applied topically at a 10% concentration

DRUG

Ketamine

To be applied topically at a 10% concentration

DRUG

Loperamide

To be applied topically at a 5% concentration

DRUG

Gabapentin

To be applied topically at a 6% concentration

DRUG

placebo

Compounding base to be used alone as a placebo

Sponsors & Collaborators

  • Mae Stone Goode Foundation

    collaborator OTHER

  • University of Rochester

    lead OTHER

Principal Investigators

  • Adrienne D Bonham, MD · University of Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099006 on ClinicalTrials.gov