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Completed

NCT Number: NCT04705883

Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

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

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Key information

Conditions

Vulvar Atrophy Breast Cancer Breast Diseases Breast Neoplasms Genitourinary Syndrome of Menopause Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prasterone (DHEA), Micronized

Drug

Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.

Other names: Intrarosa

Primary outcomes

  1. Estradiol

    Time frame: 12 months

    Ultrasensitive blood estradiol, serum levels measured in pg/ml

Secondary outcomes

  1. Vaginal pH

    Time frame: 12 months

    vaginal pH measured by ph roll from 1 to 14 (the lesser the better)

  2. Vaginal maturation index

    Time frame: 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.

  3. Vaginal health index

    Time frame: 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.

  4. Female Sexual Function Index

    Time frame: 12 months

    Questionaire from 18 to 90 (min-max). The higher the better.

  5. Social Functioning Questionnaire

    Time frame: 12 months

    Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: VIBRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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