Estrogen + probiotics / dehydroepiandrosterone / Vulvovaginal Atrophy · Phase 4 Trial

GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed Phase 4 randomized controlled trial comparing four local treatments for vulvovaginal atrophy in breast cancer patients receiving endocrine therapy. The registry record documents the study design and planned endpoints but does not report results; the small sample size (31 participants) and surrogate endpoints (symptom questionnaires and hormone concentrations) limit the strength of inference pending publication of results.

What was studied

Phase 4, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Vulvovaginal Atrophy, Breast Cancer; Female; age from 18 Years. Intervention: Estrogen; Dehydroepiandrosterone; Estrogen + probiotics; Moisturizer. Compared with: DRUG: Moisturizer. n = 31. 1 site: Belgium.

Key findings

Safety

Surrogate endpoints (questionnaires, hormone levels) do not directly measure clinical benefit or safety

Who this may help

Once results are published, this trial may inform choice of local treatment for vulvovaginal atrophy in breast cancer patients on endocrine therapy, a population currently reported as inadequately treated. The small sample and surrogate endpoints mean results should be considered exploratory pending replication.

Plain-language summary

This is a completed Phase 4 randomized trial with 31 participants and surrogate endpoints (symptom questionnaires, hormone concentrations); results are not yet published in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the EQ5D-questionnaire. (assessed at 12 weeks); Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the FACT-ES questionnaire. (assessed at 12 weeks); Change in sex steroid hormone concentrations in a time frame of 12 weeks. (assessed at 12 weeks)

DesignPhase 4, Interventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationVulvovaginal Atrophy, Breast Cancer; Female; age from 18 Years

Sample size31

InterventionEstrogen; Dehydroepiandrosterone; Estrogen + probiotics; Moisturizer

ComparatorDRUG: Moisturizer

Setting1 site: Belgium

Reported figures

Quoted from the source exactly as published.

Sample size31

PhasePhase 4

Study designProspective active-controlled randomized trial

Primary outcome measure 1Change in symptoms and quality of life using EQ5D-questionnaire at 12 weeks

Primary outcome measure 2Change in symptoms and quality of life using FACT-ES questionnaire at 12 weeks

Primary outcome measure 3Change in sex steroid hormone concentrations at 12 weeks

Clinical bottom line

Caveats

Registry record does not report results; outcome data not available for interpretation
No information on blinding, allocation concealment, or potential sources of bias
Small sample size (31 total) limits statistical power across four treatment arms
Surrogate endpoints (questionnaires, hormone levels) do not directly measure clinical benefit or safety

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Prospective active-controlled randomized trial with four treatment arms

Directness

strong

Directly addresses vulvovaginal atrophy treatment in breast cancer patients on endocrine therapy

Consistency

insufficient

Registry record only; no results reported to assess consistency with other evidence

Risk of bias

insufficient

Registry record does not report methods, blinding status, or allocation concealment details

Sample adequacy

limited

Small sample size of 31 participants across four treatment arms limits statistical power

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05562518). This is a study registration, not published results. Lead sponsor: University Hospital, Ghent. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 31 participants (ACTUAL). Conditions: Vulvovaginal Atrophy, Breast Cancer. Interventions: DRUG: Estrogen; DRUG: dehydroepiandrosterone; DRUG: Estrogen + probiotics; DRUG: Moisturizer. Primary outcome measures: Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the EQ5D-questionnaire. , 12 weeks; Change in symptoms and quality of life after implementation of treatment in a time frame of 12 weeks using the FACT-ES questionnaire. , 12 weeks; Change in sex steroid hormone concentrations in a time frame of 12 weeks. , 12 weeks. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Estrogen + probioticsdehydroepiandrosteroneUniversity Hospital, GhentVulvovaginal AtrophyEstrogenNCT05562518MoisturizerBreast Cancer