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Study identifier: NCT07563621 Synced from ClinicalTrials.gov · July 29, 2026
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Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors

Condition: Genitourinary Syndrome of Menopause (GSM) · Breast Cancer · Vulvovaginal Atrophy  ·  Sponsor: Jessa Hospital

PhaseN/A
Planned participants264
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersYes

About this study

Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency. The prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls. For this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy …

This description comes directly from the study's public registry record.

Talk to the study team

Jeroen Mebis, Prof. Dr.  ·  +32 11 33 72 21  ·  jeroen.mebis@jessazh.be

Sofie Van Duffel, MSc  ·  +32 11 33 72 31  ·  sofie.vanduffel@uhasselt.be

Always discuss trial participation with your own doctor first.

Locations (1)

Jessa HospitalHasselt, Limburg, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT07563621