ClinicalTrials.gg
Not yet recruitingNCT07581288MIRAUpdated May 12, 2026

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

An observational study in Uterine Bleeding, Uterine Cancer and Uterine Neoplasms, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of British Columbia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
35 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
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In context

Uterine Hemorrhage

90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.

This study's planned enrollment of 50 is below the median of 122 across 27 observational studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 35 years and older
  • Have experienced AUB

Exclusion criteria

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 , ovulation stimulants, hormone replacement, etc.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • MIRA Participants

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

06

What researchers measure

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

07

Study locations

1 site
  • Vancouver General Hospital Research Pavillion
    Vancouver, British Columbia V5Z 1N1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07581288
Responsible party
Aline Talhouk (Assistant Professor, University of British Columbia) — Principal investigator
First posted
May 12, 2026
Start date
May 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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