Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors



Full Title of Study: “Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 8, 2021

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.


  • Drug: Prasterone (DHEA), Micronized
    • Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.

Arms, Groups and Cohorts

  • Other: Prasterone
    • 10 patients will be treated using prasterone during 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • Estradiol
    • Time Frame: 12 months
    • Ultrasensitive blood estradiol, serum levels measured in pg/ml

Secondary Measures

  • Vaginal pH
    • Time Frame: 12 months
    • vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
  • 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.
  • 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.
  • Female Sexual Function Index
    • Time Frame: 12 months
    • Questionaire from 18 to 90 (min-max). The higher the better.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Clinic of Barcelona
  • Provider of Information About this Clinical Study
    • Principal Investigator: Camil Castelo-Branco, Principal Investigator, Clinical Professor – Hospital Clinic of Barcelona
  • Overall Official(s)
    • Camil Castelo-Branco, Principal Investigator, Hospital Clinic of Barcelona
  • Overall Contact(s)
    • EDUARD M MENSION, 626207171,

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