Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Breast Cancer Clinical Trial

— VIBRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705883
• Other study ID #: Versión 4- 20/09/2020
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Atrophy
• Breast Cancer
• Breast Neoplasms
• Genitourinary Syndrome of Menopause
• Vulvar Atrophy

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