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Clinical Trial Summary

To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.


Clinical Trial Description

LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)

Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03628092
Study type Interventional
Source Royal North Shore Hospital
Contact Antonia Pearson, BMed
Phone +61402308664
Email antonia.pearson@sydney.edu.au
Status Recruiting
Phase N/A
Start date July 24, 2018
Completion date October 1, 2021

See also
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