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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
Must not have
Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of desire for future fertility, morbid obesity, or multiple co-morbidities
Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am older than 18 years.
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I have not received any treatment for my current diagnosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have grade 1 endometrial cancer and do not wish to have children. I am not severely obese or have multiple health issues.
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My biopsy shows I have grade 2 or higher endometrial cancer.
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My cancer has spread outside the uterus, confirmed by imaging or surgery.
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I have a birth defect or condition that changes the shape of my uterus.
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I have a condition that makes me more prone to infections, like AIDS or leukemia.
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I have been diagnosed with genital actinomycosis.
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I have breast cancer.
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I have acute liver disease or a history of liver tumors.
Select...
I have an infection in my pelvic area.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of the Levonorgestrel Intrauterine Device (IUD)
Response Rate at 12 Month
Secondary study objectives
Quality of Life Score Using the Short Form-36 (SF-36) Survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,070 Previous Clinical Trials
1,802,739 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
102 Patients Enrolled for Endometrial Hyperplasia
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,119 Total Patients Enrolled
11 Trials studying Endometrial Hyperplasia
3,546 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
~4 spots leftby Dec 2025
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