Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Vulvar Atrophy Breast Cancer Genitourinary Syndrome of Menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prasterone

10 patients will be treated using prasterone during 6 months.

Group Type OTHER

Prasterone (DHEA), Micronized

Intervention Type DRUG

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

Interventions

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Prasterone (DHEA), Micronized

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

Intervention Type DRUG

Other Intervention Names

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Intrarosa

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No