drugset / Trial / NCT05562518

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

NCT05562518

Phase 4 Active not recruiting 160 enrolled University Hospital, Ghent University Ghent · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-03-21
Primary completion
2026-03-02
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dehydroepiandrosterone Other / unclassified Other
Comparator Hyaluronic Acid Other / unclassified Other
Comparator oestriol Unknown Other