Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Endometrial Intraepithelial Neoplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Menstrual Cycle | — | UNRESOLVED | — |
| Reproductive Endocrinology | — | UNRESOLVED | — |
| Uterine Bleeding | — | UNRESOLVED | — |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- MIRA Participants
- description
- Individuals aged 35 or older who have experienced abnormal uterine bleeding.
Primary outcomes (3)
- measure
- Urinary Hormone Levels (Mira Monitor)
- timeFrame
- 3 months
- description
- 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).
- measure
- Menstrual Bleeding Severity
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available