VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.
Hospital Clínic de Barcelona
Barcelona, Spain
Estradiol
Ultrasensitive blood estradiol, serum levels measured in pg/ml
Time frame: 12 months
Vaginal pH
vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
Time frame: 12 months
Vaginal maturation index
vaginal maturation index meadured by vaginal citology on percentage from 0 to 100 divided in superficial, intermediate and basal cells. The more superficial, the better.
Time frame: 12 months
Vaginal health index
To describe if there is a correlation between changes in the visual examination of the vagina. using the vaginal health index: from 5 to 25 (min-max). The higher the better.
Time frame: 12 months
Female Sexual Function Index
Questionaire from 18 to 90 (min-max). The higher the better.
Time frame: 12 months
Social Functioning Questionnaire
Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.
Time frame: 12 months
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