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

Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Genitourinary Syndrome of Menopause; Vulvar Atrophy
• Intervention / Treatment: Drug: Prasterone (DHEA), Micronized

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prasterone; 10 patients will be treated using prasterone during 6 months.	Drug: Prasterone (DHEA), Micronized; Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.; Other Names: Intrarosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estradiol	Ultrasensitive blood estradiol, serum levels measured in pg/ml	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal pH	vaginal pH measured by ph roll from 1 to 14 (the lesser the better)	12 months
Vaginal maturation index	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.	12 months
Vaginal health index	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.	12 months
Female Sexual Function Index	Questionaire from 18 to 90 (min-max). The higher the better.	12 months
Social Functioning Questionnaire	Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.	12 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Camil Castelo-Branco, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; Genitourinary Syndrome of Menopause
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Pathological Conditions, Anatomical; Breast Neoplasms; Atrophy; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: Versión 4- 20/09/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No