Status:
COMPLETED
CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Breast Cancer
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 treatm...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients diagnosed with breast cancer
- Menopause: spontaneous, surgical or chemotherapy induced
- One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria
- On exam, clinical findings of atrophy: thin, dry, pale vagina
- Age\>18
- Normal Pap smear within 3 years
- Exclusion criteria:
- Menstruation
- Chemotherapy
- Vaginal bleeding which did not underwent evaluation
- Concurrent treatment with topical estrogen
- Previous vulvar, vaginal or cervical dysplasia\\ cancer
Exclusion
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04517370
Start Date
February 1 2019
End Date
December 30 2023
Last Update
March 12 2024
Active Locations (1)
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1
Ahinoam Lev-Sagie
Lapid, Israel, 73133