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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07581288

Acronym

MIRA

Enrollment

Registered

2026-05-12

Start date

2026-05-01

Completion date

2026-09-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
Acceptability and Feasibility of Mira Monitor	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.
Urinary Hormone Levels (Mira Monitor)	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	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.

Countries

Canada

Outcome results