Laser vs Hyaluronic Acid for GSM in Breast Cancer

Last updated: January 17, 2024
Sponsor: Medical University of Graz
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Cikatridina

Juliet Feminine Laser

Clinical Study ID

NCT03816735
30-225 ex 17/18
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

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).

Eligibility Criteria

Inclusion

Inclusion criteria

  • genital symptoms of dryness/ burning/ irritation
  • and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain
  • and/or symptoms of urgency and dysuria or recurrent urinary tract infection
  • Age 18-80
  • History of BC and/ or DCIS
  • Completed locoregional therapy
  • Current antihormonal therapy for BC possible
  • Intravaginal treatment with creams/ suppositories other than study medicationshould beceased during the trial

Exclusion

Exclusion criteria:

  • Current or past genitourinary malignancy
  • Abnormal PAP smear
  • Current genitourinary tract infection
  • Abnormal uterine bleeding
  • photosensitive medication

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Cikatridina
Phase:
Study Start date:
January 24, 2019
Estimated Completion Date:
December 31, 2024

Study Description

Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress Urinary Incontinence), GSM and vaginal laxity. Asclepion' s headquarters are located in "Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany".

Device II- Suppository The second device is a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.

Connect with a study center

  • Department of Obstetrics, Medical University Graz

    Graz, 8045
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.