Vulvovaginal Atrophy Clinical Trial
Official title:
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
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.
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.
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||
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