Clinical trial · Interventional
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
NCT04705883CI-TRIAL-00056660VIBRAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
| Vulvar Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prasterone (DHEA), Micronized | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Prasterone
- description
- 10 patients will be treated using prasterone during 6 months.
- interventionNames
- Drug: Prasterone (DHEA), Micronized
Primary outcomes (1)
- measure
- Estradiol
- timeFrame
- 12 months
- description
- Ultrasensitive blood estradiol, serum levels measured in pg/ml
Secondary outcomes (5)
- measure
- Vaginal pH
- timeFrame
- 12 months
- description
- vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.