Measurement of Urinary Hormones in Patients With Abnormal Uterine Bleeding to Study Uterine Cancer Progression

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: MIRA Participants

Trial outcomes

Primary outcomes

1

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).

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: