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

Overview

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: January 11, 2021

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: Treatment Arm
    • 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
  • 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
  • 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)
  • Female Sexual Function Index
    • Time Frame: 12 months
    • Questionaire from 18 to 90 (min-max)
  • Social Functioning Questionnaire
    • Time Frame: 12 months
    • Questionaire SF12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max)

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 Contact(s)
    • EDUARD M MENSION, 626207171, edmension@gmail.com

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