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Behavioral Weight Loss + Progestin for Endometrial Hyperplasia
Phase 2
Waitlist Available
Led By Andrea R Hagemann, M.D., MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 4 years)
Awards & highlights
Study Summary
This trial is studying if a weight loss strategy combined with progestin can help prevent/reverse endometrial cancer in premenopausal women wanting to preserve their fertility.
Who is the study for?
This trial is for premenopausal women aged 18-45 with obesity (BMI ≥ 30) and a diagnosis of complex atypical endometrial hyperplasia or grade 1 endometrial cancer, who want to preserve their uterus. They should be able to have an IUD placed, may already be on progestin therapy for less than six months, and must not have been in a weight loss trial recently or currently receiving chemotherapy/radiation.Check my eligibility
What is being tested?
The study tests if combining a behavioral weight loss intervention via telemedicine with progestin treatment is more effective in preserving the uterus without atypia compared to just progestin treatment plus enhanced usual care. Participants will also receive either oral progestin or a levonorgestrel-releasing IUD.See study design
What are the potential side effects?
Possible side effects include those related to progestin such as worsening insulin resistance, potential relapse of AEH or endometrial cancer, and general risks associated with intrauterine devices like discomfort or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with atypia-free biopsy with uterine preservation
Secondary outcome measures
Atypia-free survival or endometrial cancer-free survival
Change in Cancer Worry Impact Events Scale (CWIES)
Change in weight
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss InterventionExperimental Treatment3 Interventions
The levonorgestrel-releasing IUD is used in this study as per standard care.
The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.
Group II: Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual CareActive Control2 Interventions
The levonorgestrel-releasing IUD is used in this study as per standard care.
Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies.
If participants in the enhanced usual care group do not achieve atypia-free uterine preservation (i.e., have not resolved their hyperplasia or grade 1 endometrial cancer) by one year of enrollment and continue to desire uterine preservation with progestin treatment, they will cross over to receive the telemedicine behavioral intervention for the second year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progestin
2015
Completed Phase 4
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,571 Total Patients Enrolled
10 Trials studying Endometrial Hyperplasia
2,019 Patients Enrolled for Endometrial Hyperplasia
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,613 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
96 Patients Enrolled for Endometrial Hyperplasia
Andrea R Hagemann, M.D., MSCIPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
96 Patients Enrolled for Endometrial Hyperplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use an IUD due to certain health conditions or allergies.I am not currently receiving chemotherapy or radiation for cancer.I am currently taking medication for weight management or short-term weight loss.I have AEH or grade 1 endometrial cancer and am on progestin therapy.I have been diagnosed with a specific type of early-stage uterine cancer or pre-cancer.I have taken or am currently taking progestin.I do not have any serious illnesses like heart failure or uncontrolled infections.I have taken or am currently taking metformin.I am a premenopausal woman with a uterus.I am able to care for myself and perform daily activities.I am between 18 and 45 years old.I have used progestin for 6 months or less for my AEH or grade 1 endometrial cancer.I want to preserve my fertility and keep my uterus.I am willing to have an LNG-IUD placed for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
- Group 2: Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to volunteer for this experiment?
"Clinical trials.gov shows that this trial has stopped recruiting participants, with the initial post on October 31st 2023 and last update occurring on June 5th 2023. That said, 1400 other clinical studies are in need of patients as we speak."
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