Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT06007027
Eligibility Criteria:
Inclusion Criteria:
* Breast cancer survivor in endocrine therapy
* Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
* Able to read and understand Danish
* Able to give written informed consent
Exclusion Criteria:
* Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
* Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
* Use of Chemotherapy (6 months prior to the baseline visit)
* Acute urinary tract infection or active genital infection
* History of vaginal reconstructive surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06007027
Study Brief:
Protocol Section:
NCT06007027