Levonorgestrel IUD for Uterine Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Levonorgestrel

Disqualifiers: Grade 2 cancer, Extrauterine spread, Uterine anomaly, Liver disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

69 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What data supports the effectiveness of the treatment Levonorgestrel-Releasing Intrauterine System for uterine cancer?

Research shows that the Levonorgestrel-Releasing Intrauterine System (LNG-IUS) can help manage early-stage endometrial cancer and atypical hyperplasia (a condition where the lining of the uterus becomes too thick) by improving endometrial thickness and pregnancy outcomes. It has also been used effectively in combination with other treatments to preserve fertility in young women with early endometrial cancer. ^{1 2 3 4 5}

Is the Levonorgestrel IUD generally safe for use in humans?

The Levonorgestrel IUD is generally considered safe for use in humans, with most side effects being minor, such as changes in menstrual bleeding patterns. Some studies suggest a slight increase in breast cancer risk, but this is not consistently observed across all research. ^{1 6 7 8 9}

How does the Levonorgestrel-Releasing Intrauterine System differ from other treatments for uterine cancer?

The Levonorgestrel-Releasing Intrauterine System (LNG-IUD) is unique because it delivers hormones directly to the uterus, which can help treat early-stage uterine cancer and complex atypical hyperplasia while preserving fertility. Unlike systemic treatments, it provides localized hormone therapy, reducing the risk of side effects and potentially lowering the risk of developing endometrial cancer by up to 50%. ^{1 2 6 10 11}

Research Team

Shannon N Westin

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am a woman.

I am older than 18 years.

I have a specific type of uterine cancer, want to have children, am very overweight, or have serious health issues.

Exclusion Criteria

I have grade 1 endometrial cancer and do not wish to have children. I am not severely obese or have multiple health issues.

My biopsy shows I have grade 2 or higher endometrial cancer.

My cancer has spread outside the uterus, confirmed by imaging or surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo placement of a levonorgestrel-releasing intrauterine system

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 1 year, then periodically

Treatment Details

Interventions

• Levonorgestrel-Releasing Intrauterine System

Trial Overview 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.

Participant Groups

Group I: Treatment (levonorgestrel-releasing intrauterine system) Experimental Treatment 3 Interventions

Patients undergo placement of a levonorgestrel-releasing intrauterine system.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The levonorgestrel-releasing intrauterine system, particularly the Mirena® device, can significantly reduce the risk of endometrial carcinoma by up to 50% compared to the general population, making it an effective preventive measure against certain cancers in women.

While Mirena® may slightly increase the risk of breast carcinoma by about 20%, it also lowers the risk of other cancers such as cervical, ovarian, pancreatic, and lung carcinomas, suggesting its potential as a primary prevention strategy, especially for women who are obese or overweight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Levonorgestrel-releasing intrauterine system Mirena® (Bayer) for the prevention and treatment of endometrial adenocarcinoma and the incidence of other malignancies in women]. Jóźwik, M., Jóźwik, M., Modzelewska, B., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Three-year follow-up of the use of a levonorgestrel-releasing intrauterine system in hormone replacement therapy. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Fertility-Sparing Treatment of Early Endometrial Cancer and Complex Atypical Hyperplasia in Young Women of Childbearing Potential. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

LNG-IUS combined with progesterone ameliorates endometrial thickness and pregnancy outcomes of patients with early-stage endometrial cancer or atypical hyperplasia. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Segmented in vitro fertilization and frozen embryo transfer in levonorgestrel-releasing intrauterine device treated patients with endometrial cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Ectopic pregnancy with levonorgestrel releasing intrauterine system. [2013]

6. Poland pubmed.ncbi.nlm.nih.gov

[Levonorgestrel-releasing intrauterine system Mirena® (Bayer) for the prevention and treatment of endometrial adenocarcinoma and the incidence of other malignancies in women]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The levonorgestrel-releasing intrauterine system in modern gynaecology. [2013]

9. New Zealand pubmed.ncbi.nlm.nih.gov

A risk-benefit assessment of the levonorgestrel-releasing intrauterine system. [2018]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Conservative hysteroscopic treatment of stage I well differentiated endometrial cancer in patients with high surgical risk: a pilot study. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of Low-Risk Endometrial Cancer and Complex Atypical Hyperplasia With the Levonorgestrel-Releasing Intrauterine Device. [2019]