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Therapy to Prevent Sexual Pain in Breast Cancer Survivors

NCT01539317 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-04-14

Study results available
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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.

Conditions

Interventions

DRUG

Topical liquid lidocaine

active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule

DRUG

Topical saline

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

Sponsors & Collaborators

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Martha Goetsch, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01539317 on ClinicalTrials.gov