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

NCT07581288 | Not Yet Recruiting

• 1 other identifier: H24-03180
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Bleeding; Uterine Cancer; Uterine Neoplasms; Endometrial Cancer; Endometrial Hyperplasia; Endometrial Intraepithelial Neoplasia; Menstrual Cycle; Reproductive Endocrinology

Keywords

Digital Health; Urinary Hormones; Uterine Cancer; Abnormal Uterine Bleeding; Menstrual Cycle Tracking; At-home monitoring; Follicle Stimulating Hormone; Luteinizing Hormone; Estrogen; Progesterone

Outcome Measures

Primary Outcomes (3)

• 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).

  3 months

• 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.

  3 months

• 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.

  3 months

Study Arms (1)

MIRA Participants

Individuals aged 35 or older who have experienced abnormal uterine bleeding.

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 35 or older who have undergone an endometrial biopsy for investigation of abnormal uterine bleeding.

You may qualify if:

• years and older
• Have experienced AUB

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital Research Pavillion

Vancouver, British Columbia, V5Z 1N1, Canada

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Uterine Neoplasms; Endometrial Neoplasms; Endometrial Hyperplasia; Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

CA (1)