Clinical trial · Interventional
GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.
NCT05562518CI-TRIAL-00121856GRACEcompletedPhase 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)
In this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.
Conditions
Conditions (2)
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 |
| Vulvovaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dehydroepiandrosterone | Drug | — | UNRESOLVED |
| Estrogen | Drug | — | UNRESOLVED |
| Estrogen + probiotics | Drug | — | UNRESOLVED |
| Moisturizer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Estrogen
- description
- locally administered estrogen (oestriol)
- interventionNames
- Drug: Estrogen
- type
- ACTIVE_COMPARATOR
- label
- Dehydroepiandrosterone
- description
- locally administered dehydroepiandrosterone (DHEA)
- interventionNames
- Drug: dehydroepiandrosterone
- type
- ACTIVE_COMPARATOR
- label
- Estrogen + probiotics
- description
- locally administered estrogen (oestriol) + probiotics
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* breast cancer patient
* current endocrine therapy (AI or SERM)
* postmenopausal status, defined by:
* 12 months amenorrhoea or
* 6 months amenorrhoe and FSH level of \>40 mIU/mL or
\*\>6 weeks after bilateral oophorectomy or
* induced postmenopause (ovarian function suppression using GnRH-analogue)
* presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)
Exclusion Criteria:
* a history of vulvar or vaginal surgery (Inclusion is possible after hysterectomy. For these subjects no microbiome sampling will be performed. Microbiome analysis is not performed for these subjects.)
* current other vulvar or vaginal disease
* recent use of antibiotics/antifungals/corticosteroids (less than 1 month)
* current use of vaginal hormonal treatment or vaginal moisturizer: inclusion is possible after a washout period of 4 weeksReferences
Publications (0)
Data not yet available
No reference posted for this study.