Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors (VIBRA)

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

Breast Cancer

Vulvar Atrophy

Genitourinary Syndrome of Menopause

Treatments

Drug: Prasterone (DHEA), Micronized

Study type

Interventional

Funder types

Other

Identifiers

NCT04705883

Versión 4- 20/09/2020

Details and patient eligibility

About

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

Full 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.

Enrollment

10 patients

Sex

Female

Volunteers

No Healthy Volunteers

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