NCT04517370|Completed
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Sponsor study identifier
interventional
36
1 country
1
Study Start
February 1, 2019
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2019
Actual (reported)August 16, 2020
Actual (reported)August 18, 2020
Actual (reported)June 30, 2023
Actual (reported)December 30, 2023
Actual (reported)Change in dryness
Change in VAS before and after completion of treatment for dryness
Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
Change in dyspareunia
Change in VAS before and after completion of treatment for dyspareunia
Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
Each patient will be treated once every 20-40 days, for a total of 3 laser treatments. In every visit during the study, patients will undergo gynecological examination and will complete questionnaires evaluating GSM symptoms, using a visual analogue scale (VAS) for each symptom (vaginal dryness, dyspareunia, discharge, itching and/or stinging, vaginal bleeding and dysuria) as well as treatment induced pain and side effects.
Each patient will be treated once every 20-40 days, for a total of 3 Sham treatments, in a similar procedure not using an active laser energy. Patients will be assessed in a similar manner. Following 3 Sham-treatments patients in the placebo group will be offered the laser treatment in an open-label study .
The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse). Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ahinoam Lev-Sagie
Lapid, 73133, Israel
Ahinoam Lev-Sagie, MD
Hadassah Medical Organization
36 participants (actual enrollment reported by the registry).
First Submitted
August 16, 2020
First Posted
August 18, 2020
Study Start
February 1, 2019
Actual (reported)Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
December 30, 2023
Actual (reported)Last Updated
March 12, 2024
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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