Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Dehydroepiandrosterone

Criteria

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