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Provera for Endometrial Cancer Risk Reduction (RESToRE Trial)

Phase 4

Recruiting

Led By Aline Talhouk, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

RESToRE Trial Summary

This trial will screen and assess risk reducing interventions for those at increased risk of endometrial cancer. A risk model and Progesterone test will identify those to receive standard of care and lifestyle interventions.

Who is the study for?

This trial is for postmenopausal individuals at least three years past their last menstrual period, who still have an intact uterus. It's not open to those on hormone therapy for menopause, taking male hormones or anti-endocrine drugs like tamoxifen, using aromatase inhibitors, experiencing abnormal uterine bleeding, or with an IUD.Check my eligibility

What is being tested?

The study tests the feasibility of a screening method and risk-reducing treatments in people at high risk for endometrial cancer. Participants will take Provera (medroxyprogesterone acetate) for ten days; if they bleed afterwards, it indicates potential endometrial proliferation and leads to standard care including possible biopsy and hormone therapy.See study design

What are the potential side effects?

Provera may cause side effects such as nausea, breast tenderness, headache, insomnia, mood swings and withdrawal bleeding. Long-term use can sometimes lead to increased risks of blood clots or changes in menstrual flow when used by premenopausal women.

RESToRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of Proposed Screening Method

Feasibility of Proposed Screening Method

Secondary outcome measures

Proposed Screening Method Program Evaluation

RESToRE Trial Design

1Treatment groups

Experimental Treatment

Group I: Progesterone Challenge TestExperimental Treatment1 Intervention

10-day course of medroxyprogesterone acetate (Provera) 10 mg per os (po) daily.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,868 Total Patients Enrolled

2 Trials studying Endometrial Cancer

1,030 Patients Enrolled for Endometrial Cancer

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,317 Total Patients Enrolled

2 Trials studying Endometrial Cancer

2,615 Patients Enrolled for Endometrial Cancer

Canadian Cancer Society (CCS)OTHER

78 Previous Clinical Trials

37,495 Total Patients Enrolled

Media Library

Progesterone Challenge Test Clinical Trial Eligibility Overview. Trial Name: NCT05651282 — Phase 4

Endometrial Cancer Research Study Groups: Progesterone Challenge Test

Endometrial Cancer Clinical Trial 2023: Progesterone Challenge Test Highlights & Side Effects. Trial Name: NCT05651282 — Phase 4

Progesterone Challenge Test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651282 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Progesterone Challenge Test been given regulatory approval by the FDA?

"The Progesterone Challenge Test has been approved, thus the safety rating was marked at a 3."

Answered by AI

Is this experiment seeking volunteers at the moment?

"This clinical trial is open for enrollment, as detailed on the official website. Initially posted in March 15th 2023 and last updated on May 8th of the same year, it seeks participants to join its study."

Answered by AI

How many individuals are currently undergoing treatment as part of this research?

"Affirmative. Clinicaltrials.gov confirms that, with a posting date of March 15th 2023 and an update on May 8th 2023, this clinical trial is currently accepting participants. The goal is to enroll 250 patients from one location."

Answered by AI

Recent research and studies

Journal of Biomedical InformaticsJournal

Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support

Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.

Journal of Biomedical InformaticsJournal

The Redcap Consortium: Building an International Community of Software Platform Partners

Harris, Paul A., Robert Taylor, Brenda L. Minor, Veida Elliott, Michelle Fernandez, Lindsay O'Neal, Laura McLeod, et al.. 2019. “The Redcap Consortium: Building an International Community of Software Platform Partners”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2019.103208.

clinicaltrials.govStudy

Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer

Aline Talhouk 2023. "Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05651282.