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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 35 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Uterine Bleeding, Uterine Cancer, Uterine Neoplasms, Endometrial Cancer, Endometrial Hyperplasia, Endometrial Intraepithelial Neoplasia

Keywords

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

Medical subject headings

Uterine Hemorrhage, Uterine Neoplasms, Endometrial Neoplasms, Endometrial Hyperplasia, Metrorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 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.

   Measured: 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.

   Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 May 2026
2. Study startMay 2026 (estimated)
3. Primary completionSep 2026 (estimated)
4. Study completionSep 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Uterine BleedingStudies of the same condition, open and under way.
• More trials run by University of British ColumbiaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.