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Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors (VIBRA)

Primary Purpose

Vulvar Atrophy, Breast Cancer, Genitourinary Syndrome of Menopause

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Prasterone (DHEA), Micronized
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vulvar Atrophy focused on measuring Breast Cancer, Genitourinary Syndrome of Menopause

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prasterone

Arm Description

10 patients will be treated using prasterone during 6 months.

Outcomes

Primary Outcome Measures

Estradiol
Ultrasensitive blood estradiol, serum levels measured in pg/ml

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2021
Last Updated
February 20, 2022
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04705883
Brief Title
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
Acronym
VIBRA
Official Title
Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Atrophy, Breast Cancer, Genitourinary Syndrome of Menopause
Keywords
Breast Cancer, Genitourinary Syndrome of Menopause

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasterone
Arm Type
Other
Arm Description
10 patients will be treated using prasterone during 6 months.
Intervention Type
Drug
Intervention Name(s)
Prasterone (DHEA), Micronized
Other Intervention Name(s)
Intrarosa
Intervention Description
Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.
Primary Outcome Measure Information:
Title
Estradiol
Description
Ultrasensitive blood estradiol, serum levels measured in pg/ml
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Vaginal pH
Description
vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
Time Frame
12 months
Title
Vaginal maturation index
Description
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.
Time Frame
12 months
Title
Vaginal health index
Description
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.
Time Frame
12 months
Title
Female Sexual Function Index
Description
Questionaire from 18 to 90 (min-max). The higher the better.
Time Frame
12 months
Title
Social Functioning Questionnaire
Description
Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.
Time Frame
12 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camil Castelo-Branco
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

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