NCT05651282CompletedPhase 4
Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer
Uterine Cancer Risk Reducing Strategies in Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
This study proposes to assess feasibility and acceptability of screening and risk reducing interventions in individuals at increased for endometrial cancer (EC). The investigators will use an epidemiological risk model to participants' absolute risk of developing EC in the next 10 years. Those whose absolute risk is 2% or greater or who have a Body Mass Index (BMI) higher than 34.9 will proceed to a second screening test (the Progesterone Challenge Test or the PCT) used to identify those with endometrial proliferation. The PCT consists of taking a ten-day course of medroxyprogesterone acetate (Provera) 10 mg per os daily. If withdrawal bleeding is experienced during the ten days up to two weeks since the final dose, this is considered a positive test result. PCT positive participants will receive standard of care treatment which may include endometrial biopsy and hormone therapy. As part of this project, the investigators will test the utility of self-collected vaginal sampling to measure DNA mutations and microbiome characteristics to help refine who could forego an endometrial biopsy in the future. Participants identified through the PCT will receive a lifestyle intervention through the Small Steps for Big Changes program.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 11 Oct 2022
- Start date
- Mar 2023
- Primary completion date
- Nov 2025
- Lead sponsor
- University of British Columbia
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT05651282
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 96
- From Mar 2023 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals taking hormone therapy for menopause (including vaginal estrogen)
- Individuals on anti-endocrine therapy (such as tamoxifen)
- Individuals on aromatase inhibitor therapy
Other illness
- Individuals who have experienced abnormal uterine bleeding
Other
- Individuals taking male hormones,
- Individuals who have an Intrauterine Device (IUD)
Who the study is looking for
- Individuals are postmenopausal (must be three (3) years past last menstrual period)
- Individuals have an intact uterus (have not had a hysterectomy)
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VGH Research Pavilion Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.