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Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment

NCT03833726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-12-05

No results posted yet for this study

Summary

Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

Conditions

Interventions

PROCEDURE

Experimental: LED group

5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.

PROCEDURE

Sham Comparator: Control

5 Sessions of 8 minute with device off and heated gel, 7 days apart.

Sponsors & Collaborators

  • Centro de Atenção ao Assoalho Pélvico

    lead OTHER

Principal Investigators

  • Patríca V Lordelo, PhD · Centro de Atenção Pélvica- CAAP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2023-04-20
Completion
2023-09-30

Countries

  • Brazil

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 NCT03833726 on ClinicalTrials.gov