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GRACE-trial: a Randomized Active-controlled Trial for vulvovaGinal atRophy in breAst Cancer Patients on Endocrine Therapy.
Sponsor: University Hospital, Ghent
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2022-03-21
Completion Date
2027-12-31
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
Estrogen
1 vaginal ovule daily for three consecutive weeks, followed by 1 vaginal ovule 2 times per week
dehydroepiandrosterone
1 vaginal ovule daily
Estrogen + probiotics
1 vaginal ovule daily for 12 consecutive days, followed by 1 vaginal ovule 2 times per week
Moisturizer
1 vaginal ovule daily for 14 consecutive days, followed by 1 vaginal ovule every three days
Locations (1)
University Hospital Ghent
Ghent, Belgium