Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Overview

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

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.

Interventions

  • 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, edmension@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.