Breast Cancer Clinical Trial
— VIBRAOfficial title:
Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
Verified date | February 2022 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
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 |
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