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Hormone Therapy

Levonorgestrel IUD for Uterine Cancer

Phase 2
Waitlist Available
Led By Shannon N Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than 18 years
No prior treatment for diagnoses in inclusion criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

Study Summary

This trial will test how well levonorgestrel, a type of progesterone, helps patients with endometrial cancer.

Who is the study for?
This trial is for adults over 18 with complex atypical hyperplasia or grade I endometrial cancer who haven't had prior treatments. It's suitable for those wanting to preserve fertility, have severe obesity, or significant other health issues. Exclusions include acute pelvic/liver disease, higher-grade cancers, current breast cancer/pregnancy/breastfeeding, uterine anomalies, and conditions increasing infection risk.Check my eligibility
What is being tested?
The trial tests a hormone therapy using the levonorgestrel-releasing intrauterine system (IUS) in patients with certain early-stage uterine conditions. The study aims to see if regulating hormones with this IUS can help treat these patients by balancing estrogen levels.See study design
What are the potential side effects?
While not explicitly listed here, side effects of the levonorgestrel-releasing IUS may include menstrual changes, abdominal/pelvic pain, headache/migraine, acne/skin disorders among others based on general knowledge of hormonal treatment side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.
Select...
I have not received any treatment for my current diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
Response Rate at 12 Month
Secondary outcome measures
Quality of Life Score Using the Short Form-36 (SF-36) Survey

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (levonorgestrel-releasing intrauterine system)Experimental Treatment3 Interventions
Patients undergo placement of a levonorgestrel-releasing intrauterine system.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,712 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
102 Patients Enrolled for Endometrial Hyperplasia
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,084 Total Patients Enrolled
10 Trials studying Endometrial Hyperplasia
2,046 Patients Enrolled for Endometrial Hyperplasia
Shannon N WestinPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
1,127 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
102 Patients Enrolled for Endometrial Hyperplasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
Prospective Phase II Trial of Levonorgestrel Intrauterine Device: Nonsurgical Approach for Complex Atypical Hyperplasia and Early-stage Endometrial Cancer
Westin, Shannon N., Bryan Fellman, Charlotte C. Sun, Russell R. Broaddus, Misty L. Woodall, Navdeep Pal, Diana L. Urbauer, et al.. 2021. “Prospective Phase II Trial of Levonorgestrel Intrauterine Device: Nonsurgical Approach for Complex Atypical Hyperplasia and Early-stage Endometrial Cancer”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2020.08.032.
clinicaltrials.govStudy
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
2008. "Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00788671.
All > Womens Health > Endometrial Cancer
~4 spots leftby Apr 2025
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