Clinical Trial

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

Study acronym: GRACE
Completed Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-08-14
notable Enrollment reduced: 160 -> 31 participants 2026-08-14
minor Completion moved earlier: 2027-12-31 -> 2026-03-02 2026-08-14
Trial Details
NCT Number NCT05562518
Lead Sponsor University Hospital, Ghent
Collaborators: University Ghent
Conditions Vulvovaginal Atrophy, Breast Cancer
Enrollment 31 participants
Start Date 2022-03-21
Primary Completion 2026-03-02 (estimated)
Study Completion 2026-03-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-13