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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of Proposed Screening Method
Feasibility of Proposed Screening Method
Secondary study objectives
Proposed Screening Method Program Evaluation

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,476 Previous Clinical Trials
2,493,430 Total Patients Enrolled
2 Trials studying Endometrial Cancer
1,030 Patients Enrolled for Endometrial Cancer
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,529,195 Total Patients Enrolled
2 Trials studying Endometrial Cancer
2,615 Patients Enrolled for Endometrial Cancer
Canadian Cancer Society (CCS)OTHER
82 Previous Clinical Trials
41,475 Total Patients Enrolled
Aline Talhouk, PhDPrincipal InvestigatorUniversity of British Columbia, Department of Obstetrics and Gynecology
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Endometrial Cancer
1,000 Patients Enrolled for Endometrial Cancer
Jessica McAlpine, MDPrincipal InvestigatorUniversity of British Columbia, Department of Obstetrics and Gynecology

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
~91 spots leftby Dec 2025
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