Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors

What this trial studies

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.

Conditions in scope

• Genitourinary Syndrome of Menopause (GSM)
• Breast Cancer
• Vulvovaginal Atrophy
• Genitourinary Syndrome of Menopause

Interventions

• Questionnaires (NRS, DASS-21, EORTC QLQ-C30, EORTC QLQ-BR42, FSFI, FSDS-R) (Other) — Primary objective: The study seeks primarily to provide a comprehensive overview of the burden of GSM in breast cancer patients receiving endocrine therapy (ET) or chemotherapy (CT) in comparison to a healthy control group. Secondary objective: The secondary aim of…

Who can join

Women only · Ages 18 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Women diagnosed with breast cancer stage 0, I, II, and III
• Prior to CT/ET, receiving only one of both (no combination)
• Age 18 years or above
• Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
• Dutch-speaking (be able to understand the informed consent and study-related questionnaires)
• Signed informed consent

Exclusion criteria

• Concomitant CT and ET treatment
• Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2026-03-05
• Primary completion: 2028-03-06
• Last update posted: 2026-05-04
• First posted: 2026-05-04

Sponsor & contact

Lead sponsor: Jessa Hospital (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vaginal dryness (NRS) (From enrollment up till 12 months later.)
  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal dryness. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
• Vaginal pruritus (NRS) (From enrollment up till 12 months later.)
  Description: The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal pruritus. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
• Vaginal discharge (NRS) (From enrollment up till 12 months later.)
  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal discharge. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
• Vaginal hemorrhage (NRS) (From enrollment up till 12 months later.)
  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal hemorrhage. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).
• Vaginal burning sensation (NRS) (From enrollment up till 12 months later.)
  The Numeric Rating Scale (NRS) will be used to evaluate GSM-related vaginal burning sensation. The NRS is an 11-point scale ranging from 0 (none) to 10 (maximum severity).

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.