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

NCT05562518 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Estrogen

1 vaginal ovule daily for three consecutive weeks, followed by 1 vaginal ovule 2 times per week

DRUG

dehydroepiandrosterone

1 vaginal ovule daily

DRUG

Estrogen + probiotics

1 vaginal ovule daily for 12 consecutive days, followed by 1 vaginal ovule 2 times per week

DRUG

Moisturizer

1 vaginal ovule daily for 14 consecutive days, followed by 1 vaginal ovule every three days

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Hans Verstraelen, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562518 on ClinicalTrials.gov