Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Phase 4

Completed

• Conditions: Genitourinary Syndrome of Menopause; Vulvar Atrophy; Breast Cancer
• Interventions: Drug: Prasterone (DHEA), Micronized

• Registration Number: NCT04705883
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Primary Completion: 2021-11-08
• Study Completion: 2021-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prasterone	Prasterone (DHEA), Micronized	10 patients will be treated using prasterone during 6 months.

Primary Outcome Measures

Name	Time	Method
Estradiol	12 months	Ultrasensitive blood estradiol, serum levels measured in pg/ml

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain