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NCT05903131 · ClinicalTrials.gov registry record · Phase 2
Uterine Preservation Via Lifestyle Transformation
A Phase 2 study of Endometrial Hyperplasia and Grade 1 Endometrial Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 3
- Study locations
NCT05903131 is a Phase 2 study of Endometrial Hyperplasia and Grade 1 Endometrial Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 96 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT05903131, a Phase 2 study of Endometrial Hyperplasia and Grade 1 Endometrial Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 3
- Study locations
Study Summary
Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced usual care
- BEHAVIORAL Telemedicine behavioral weight intervention
- DRUG Progestin
- DRUG Levonorgestrel-releasing IUD.
Study Locations (3)
Missouri
- Washington University School of Medicine - St Louis
New Mexico
- University of New Mexico - Albuquerque
Oklahoma
- University of Oklahoma - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05903131
The ClinicalTrials.gov registry entry for NCT05903131 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Endometrial Hyperplasia appearing as the primary indexed condition, and to 4 interventions - of which Enhanced usual care is the first listed.
NCT05903131 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Missouri, New Mexico, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05903131 about?
NCT05903131 is a clinical study titled "Uterine Preservation Via Lifestyle Transformation". Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in in...
What is the current status of trial NCT05903131?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2024-10-24. Estimated completion is 2029-10-31.
What conditions does trial NCT05903131 study?
This clinical trial studies the following conditions: Endometrial Hyperplasia, Grade 1 Endometrial Cancer.
What interventions are being tested in trial NCT05903131?
The interventions under investigation include: Enhanced usual care (BEHAVIORAL), Telemedicine behavioral weight intervention (BEHAVIORAL), Progestin (DRUG), Levonorgestrel-releasing IUD. (DRUG).
Who is sponsoring clinical trial NCT05903131?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05903131 being conducted?
This trial has 3 study locations across Missouri, New Mexico, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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