Status:
COMPLETED
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Vulvar Atrophy
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04705883
Start Date
September 1 2020
End Date
December 1 2021
Last Update
February 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036