Breast Cancer, Genitourinary Syndrome of Menopause, Vulvar Atrophy
Conditions
Keywords
Breast Cancer, Genitourinary Syndrome of Menopause
Brief summary
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Detailed description
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.
Interventions
DRUGPrasterone (DHEA), Micronized
Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH) * Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy * Cytology and / or determination of Human Papillomavirus (HPV) negative * Intention or willingness to have sex
Exclusion criteria
* To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment * To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study * To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estradiol | 12 months | Ultrasensitive blood estradiol, serum levels measured in pg/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal pH | 12 months | vaginal pH measured by ph roll from 1 to 14 (the lesser the better) |
| Vaginal maturation index | 12 months | 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. |
| Vaginal health index | 12 months | 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. |
| Female Sexual Function Index | 12 months | Questionaire from 18 to 90 (min-max). The higher the better. |
| Social Functioning Questionnaire | 12 months | Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better. |
Countries
Spain
Outcome results
None listed