Phase
Condition
Vaginal Atrophy
Treatment
intravaginal laser
Clinical Study ID
Ages 18-100 Female
Study Summary
Eligibility Criteria
Inclusion
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 afterchemotherapy, surgical or medicinally induced (GnRH analogues for the duration ofthe trial)
Exclusion
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 theinvestigator, 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 tothe measurement of the primary outcome (6 months after inclusion, 3 months afterlast laser)
Vaginal stenosis that does not allow the placement of the laser probe
Any condition that could interfere with study compliance
Study Design
Study Description
Connect with a study center
UZ Leuven
Leuven, Flemish Brabant 3000
BelgiumActive - Recruiting
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