Levonorgestrel IUD for Uterine Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a hormone-releasing device called a levonorgestrel-releasing intrauterine system (IUD) to determine its effectiveness in treating early-stage uterine cancer or complex atypical hyperplasia. These conditions often result from high estrogen levels, and levonorgestrel, a type of progesterone, may help balance hormone levels. Women diagnosed with these conditions in the last three months who have not yet received treatment, particularly those wishing to preserve fertility, with multiple health issues, or who are significantly overweight, might be suitable candidates. Participants must undergo regular check-ups and biopsies (tissue samples from the uterus) every three months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this device is safe for treating uterine cancer?

Research has shown that the levonorgestrel-releasing IUD is generally well-tolerated. Studies indicate it can reduce the risk of endometrial cancer by 33%. Some users might experience side effects such as bleeding or spotting, pelvic pain, and breast tenderness, but these are usually manageable. The FDA has already approved this treatment for other uses, indicating a strong safety record. Overall, the levonorgestrel IUD is considered a safe option for many people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for uterine cancer?

Unlike the standard treatments for uterine cancer, which often involve surgery, chemotherapy, or radiation, the levonorgestrel-releasing intrauterine system offers a unique approach by locally delivering a hormone directly to the uterus. This delivery method targets the uterine lining more precisely, potentially reducing systemic side effects that come with other treatments. Researchers are excited about this treatment because it might provide an effective, less invasive option for managing uterine cancer, preserving fertility and improving quality of life for patients.

What evidence suggests that the levonorgestrel-releasing intrauterine system might be an effective treatment for endometrial cancer?

Research has shown that the levonorgestrel-releasing intrauterine system (LNG-IUS), which releases a hormone similar to progesterone, can help treat endometrial cancer. One study found that women under 45 with a body mass index (BMI) below 30 experienced a high success rate of about 84.6% with this device. Another study indicated that the LNG-IUS can lower the risk of developing endometrial cancer by 33%. This system balances hormone levels, which may help combat endometrial cancer. Additionally, some studies have found it to be more effective than certain oral medications. Participants in this trial will have the LNG-IUS placed to evaluate its effectiveness in treating uterine cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Shannon N Westin

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Ability to comply with endometrial biopsies every 3 months

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9995869/

Levonorgestrel-releasing intrauterine system-based therapies ... Women younger than 45 with body mass index <30 kg/m2 achieved a high complete response rate of 84.6% (95% confidence interval=80.3%–88.1%) with follow-ups of at ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825821001657

The levonorgestrel intrauterine system for prevention of ... The LNG-IUS is associated with a 50 to 78% risk reduction in endometrial cancer at the population level. · The LNG-IUS is a cost-effective method of endometrial ...

3. ajog.org ajog.org/article/S0002-9378(24)00593-3/fulltext

Association of levonorgestrel-releasing intrauterine device ... Women who used LNG-IUD have a 33% reduced risk of endometrial cancer. LNG-IUD use is associated with a 14% lower risk of cervical cancer and a 9 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00788671

Levonorgestrel-Releasing Intrauterine System in Treating ... Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels. Detailed Description. PRIMARY ...

5. ejgo.org ejgo.org/DOIx.php?id=10.3802/jgo.2024.35.e62

The efficacy of the levonorgestrel intrauterine system ... LNG-IUS had a significantly higher success rate than MA during all the study phases (73% vs. 52.7% and 85.1% vs. 68.9% at 6 and 9 months, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200645/

Levonorgestrel‐releasing intrauterine system for endometrial ... Secondary outcomes included hysterectomy, hormone‐related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02397083

NCT02397083 | Levonorgestrel-Releasing Intrauterine ... This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937823002247

Expert Reviews Association between intrauterine device ... Overall, the available evidence suggests that both levonorgestrel intrauterine devices and copper intrauterine devices reduce gynecologic cancer risk.