Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

Study Overview
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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)

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.

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

Conditions
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Vulvar Atrophy, Breast Cancer, Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Drug: Prasterone (DHEA), Micronized


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prasterone<br>10 patients will be treated using prasterone during 6 months. | Drug: Prasterone (DHEA), Micronized<br>* Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.<br>* Other names: Intrarosa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol | Ultrasensitive blood estradiol, serum levels measured in pg/ml | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH | vaginal pH measured by ph roll from 1 to 14 (the lesser the better) | 12 months | 
| 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 | 
| 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 | 
| Female Sexual Function Index | Questionaire from 18 to 90 (min-max). The higher the better. | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Genitourinary Syndrome of Menopause