Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors (NCT04705883) | Clinical Trial Compass
CompletedPhase 4
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
Spain10 participantsStarted 2020-09-01
Plain-language summary
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Who can participate
SexFEMALE
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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