VIBRA: Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT04705883

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vulvar Atrophy Breast Cancer Genitourinary Syndrome of Menopause	Drug: Prasterone (DHEA), Micronized	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Nov 8, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Prasterone 10 patients will be treated using prasterone during 6 months.	Drug: Prasterone (DHEA), Micronized Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration. Other Names: Intrarosa

Arm

Intervention/Treatment

Other: Prasterone

10 patients will be treated using prasterone during 6 months.

Drug: Prasterone (DHEA), Micronized

Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.

Other Names:

Intrarosa

Outcome Measures

Primary Outcome Measures

Estradiol [12 months]
Ultrasensitive blood estradiol, serum levels measured in pg/ml

Secondary Outcome Measures

Vaginal pH [12 months]
vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
Vaginal maturation index [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 [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 [12 months]
Questionaire from 18 to 90 (min-max). The higher the better.
Social Functioning Questionnaire [12 months]
Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic de Barcelona	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator: Camil Castelo-Branco, Hospital Clinic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Camil Castelo-Branco, Principal Investigator, Clinical Professor, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT04705883

Other Study ID Numbers:

Versión 4- 20/09/2020

First Posted:

Jan 12, 2021

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Camil Castelo-Branco, Principal Investigator, Clinical Professor, Hospital Clinic of Barcelona

Breast Cancer

Genitourinary Syndrome of Menopause

Additional relevant MeSH terms:

Breast Neoplasms

Atrophy

Dehydroepiandrosterone

Study Results

No Results Posted as of Feb 22, 2022