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Laser vs Hyaluronic Acid for GSM in Breast Cancer

NCT03816735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-18

No results posted yet for this study

Summary

All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate.

After informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. Laser treatment will be performed twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up.

At baseline and three months follow-up the following questionnaires will be filled out (VAS, (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC quality of life questionnaire, ZUF-8).

Conditions

  • Urogenital Disease

Interventions

DEVICE

Cikatridina

Women are asked to insert the suppositories according to the manufacturer's protocol.

DEVICE

Juliet Feminine Laser

Women will receive the laser treatment twice during the study period.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Austria

Study Locations

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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 NCT03816735 on ClinicalTrials.gov