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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04705883
Other study ID # Versión 4- 20/09/2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date December 1, 2021

Study information

Verified date February 2022
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 1, 2021
Est. primary completion date November 8, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Hospital Clínic de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estradiol Ultrasensitive blood estradiol, serum levels measured in pg/ml 12 months
Secondary Vaginal pH vaginal pH measured by ph roll from 1 to 14 (the lesser the better) 12 months
Secondary 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
Secondary 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
Secondary Female Sexual Function Index Questionaire from 18 to 90 (min-max). The higher the better. 12 months
Secondary 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
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