Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05713435
Eligibility Criteria:
Inclusion Criteria:
Recruited participants will meet all of these criteria:
* a history of breast cancer
* premenopausal at diagnosis of breast cancer
* using AI as an adjuvant treatment
* moderate to severe symptoms of GSM (VAS ≥ 4/10)
* currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)
Exclusion Criteria:
* Not willing to abstain from vaginal intercourse for 1 week following laser therapy
* Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
* Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
* Acute urinary or genital tract infections
* A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
* Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
* Previous vaginal mesh implantation
* Abnormal result in the last cervical smear (maximum 36 month before enrollment)
* Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)
* Vaginal stenosis that does not allow the placement of the laser probe
* Any condition that could interfere with study compliance
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05713435
Study Brief:
Protocol Section:
NCT05713435