About this trial
The investigators will obtain urine hormone results and validated menstrual bleeding score from people experiencing abnormal uterine bleeding. The investigators will evaluate satisfaction and ease of use of Mira monitor. The investigators will measure recruitment rate, attrition and cycle collection completeness of data. The investigators will evaluate menstrual health literacy at baseline and at the conclusion of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
35 years and older
Have experienced AUB
Disqualifiers
Currently pregnant or become pregnant during their participation
Previous surgeries impairing the menstrual cycle (e.g. hysterectomy, bilateral oophorectomy)
Currently or in the previous 3 months on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, hormone replacement, etc.)
Trial population
Individuals aged 35 or older who have undergone an endometrial biopsy for investigation of abnormal uterine bleeding.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Urinary Hormone Levels (Mira Monitor)
Daily urinary hormone levels, including follicle-stimulating hormone (FSH), estrone-3-glucuronide (E3G), luteinizing hormone (LH), and pregnanediol glucuronide (PdG), will be measured using the Mira monitor. Participants will collect first morning urine samples and manually enter results into MyCap. Unit of Measure: Hormone concentration (as reported by Mira; e.g., mIU/mL or µg/mL).
Menstrual Bleeding Severity
Menstrual bleeding will be self-reported daily in MyCap using a modified Mansfield-Voda-Jorgensen (MVJ) Menstrual Bleeding Scale (0-6). Higher scores indicate heavier menstrual bleeding.
Acceptability and Feasibility of Mira Monitor
Acceptability and feasibility will be assessed using a study-specific questionnaire administered via MyCap at study completion. Questionnaire response scores (ordinal Likert-scale responses; e.g., 1-5 per item). Higher scores indicate greater acceptability, ease of use, and perceived usefulness.
Sponsors and contacts
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