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

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.

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Key information

Conditions

Uterine Bleeding Endometrial Cancer Endometrial Hyperplasia Endometrial Intraepithelial Neoplasia Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemorrhage Menstrual Cycle Metrorrhagia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Reproductive Endocrinology Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Hemorrhage Uterine Neoplasms

Age range

35 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vancouver General Hospital Research Pavillion

Vancouver, British Columbia, V5Z 1N1, Canada

Location contact

Research Coordinator

CONTACT

[email protected]

604-875-4111 ext. 21369

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

35 years and older
Have experienced AUB

Exclusion criteria

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.)

Treatment and study plan

Primary outcomes

Urinary Hormone Levels (Mira Monitor)

Time frame: 3 months

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

Time frame: 3 months

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

Time frame: 3 months

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 collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Quantitative Hormonal Biomarkers of Uterine Cancer Progression in Patients With Abnormal Uterine Bleeding

Acronym: MIRA

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 12, 2026
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed