CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Experimental: LED group +1 moreprocedure
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/NCT03833726
NCT03833726N/ACompleted
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Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial

Centro de Atenção ao Assoalho Pélvico·interventional·Posted Feb 7, 2019·Updated Dec 5, 2023

In Brief

A clinical study evaluating Experimental: LED group and Sham Comparator: Control for Atrophy;Vaginal and Breast Cancer. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrophy;Vaginal, Breast Cancer
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 7, 2019
Enrollment StartJan 30, 2019
Primary CompletionApr 20, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.4 years ago

Interventions

Experimental: LED groupprocedure

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

Sham Comparator: Controlprocedure

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