Mirena for Endometrial Hyperplasia

(SUNFLOWER Trial)

Not yet recruiting at 86 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: Progestins

Must not be taking: Injectable hormones

Disqualifiers: Uterine anomaly, Pregnancy, Cancer history, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to treat women with non-cancerous thickening of the uterus lining, known as nonatypical endometrial hyperplasia (NAEH). Researchers seek to determine if the Mirena device, which releases hormones inside the uterus, can safely return the lining to normal. Participants will either receive the Mirena device or take a hormone pill (medroxyprogesterone acetate) daily for six months. Women diagnosed with this condition and experiencing symptoms like abnormal vaginal bleeding might be a good fit for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using any long-acting injectable sex-hormone preparations 6 months before starting the study and any short-acting hormonal medications 6 weeks before starting. Other medications are not specifically mentioned, so it's best to discuss with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, participants using Mirena, a birth control device, reported more bleeding or spotting but experienced less nausea compared to other treatments. Research has also shown that Mirena helps prevent the thickening of the uterus lining during hormone treatments.

Mirena has been successfully used in some cases to treat a condition similar to the one being studied in this trial, with positive results in restoring the uterus lining to normal.

Since Mirena is already used for birth control, its safety is well-documented, providing doctors with extensive information about its safety profile. It appears to be well-tolerated, though some side effects, such as bleeding, may occur. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for endometrial hyperplasia?

Unlike the standard oral progestin treatments for endometrial hyperplasia, which involve taking pills daily, Mirena offers a unique approach by using an intrauterine device (IUD) that slowly releases levonorgestrel directly into the uterus. This localized delivery can provide continuous and consistent treatment, potentially reducing systemic side effects associated with oral medications. Researchers are excited about Mirena because it might offer a more convenient and potentially more effective option for managing endometrial hyperplasia without the daily hassle of remembering to take a pill.

What evidence suggests that Mirena could be an effective treatment for nonatypical endometrial hyperplasia?

Research has shown that the Mirena IUD, which releases the hormone levonorgestrel, effectively treats conditions like nonatypical endometrial hyperplasia. In this trial, participants may receive the Mirena IUD, which studies have found leads to a 93% improvement rate in this condition, significantly higher than the 66% success rate of oral treatments. Additionally, Mirena reduces the thickness of the uterine lining and controls abnormal bleeding. These findings suggest that Mirena could be a promising option for treating nonatypical endometrial hyperplasia by balancing hormone levels in the uterus. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for women who have started their periods and are diagnosed with nonatypical endometrial hyperplasia, a condition where the uterus lining becomes too thick but isn't cancerous. Participants should not be currently receiving treatment for this condition.

Inclusion Criteria

I am a woman diagnosed with NAEH regardless of my age or if I have had children.

I am a woman over 16 years old and have started my periods.

Exclusion Criteria

Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Congenital or acquired uterine or cervical anomaly including fibroids, or cervical stenosis that in the opinion of the investigator, would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity)

I haven't used long-acting sex-hormone injections in the last 6 months or short-acting ones in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Mirena inserted into the uterus or oral progestin daily for 6 months

6 months

3 visits (in-person) with a gap of 3 months between visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Medroxyprogesterone acetate
• Mirena

Trial Overview The study compares Mirena (BAY865028), an intrauterine device releasing progesterone, to oral progestins taken daily. The goal is to see if Mirena is more effective in treating the thickening of the uterus lining over a period of 6 months.

How Is the Trial Designed?

Group I: Levonorgestrel (BAY865028, Mirena) Experimental Treatment 1 Intervention

Mirena will be inserted into the participant's uterus by the investigator on Day 1. At visit 4 (after 6 months) or if a participant discontinues her study participation prematurely, the Mirena will be removed by the investigator.

Group II: Oral progestin Active Control 1 Intervention

Participants will receive 10mg oral progestin once daily, preferably always at the same time of the day, until visit 4 (after 6 months).

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9763847/

Comparison of the effectiveness of the levonorgestrel ... The primary treatment with LNG-IUD showed a 93% regression rate of endometrial hyperplasia, which was significantly higher than oral progestogens showing a 66% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352578921000370

Efficacy of the LNG-IUS for treatment of endometrial ... The LNG-IUS is gaining traction as an alternative treatment for hyperplasia and early stage EC for those women who are inoperable.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9553334/

Effect of Mirena Intrauterine Device on Endometrial Thickness ... The Mirena IUD is far more effective in the treatment of perimenopausal abnormal uterine bleeding and is helpful in reducing the thickness of the endometrium.

4. ejgo.org ejgo.org/Synapse/Data/PDFData/1114JGO/jgo-21-102.pdf

The effectiveness of levonorgestrel releasing intrauterine ... Results: Four patients had simple hyperplasia without atypia, 7 patients complex hyperplasia without atypia, and just. 1 patient complex atypical hyperplasia.

5. sgo.org sgo.org/news/complete-pathological-response-following-levonorgestrel-intrauterine-device-in-clinically-stage-i-endometrial-adenocarcinoma-results-of-a-randomized-clinical-trial/

Complete pathological response following levonorgestrel ... Six months after insertion of the hormonal IUD, biopsy results showed no signs of cancer or precancer in two-thirds of 165 women with stage I ...

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/m/mirenaius.pdf

Data Sheet Studies have demonstrated the efficacy of MIRENA in preventing endometrial hyperplasia during continuous estrogen treatment when administering estrogen ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32909630/

Levonorgestrel-releasing intrauterine system for ... The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/jog.15408

Safety and efficacy of levonorgestrel‐releasing intrauterine ... The overall recurrence rate was 56% (5/9). The median interval between removal of the LNG-IUD and recurrence was 20.5 (range: 2–30) months.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844022034387

Comparison of the effectiveness of the levonorgestrel ... Collectively, in agreement with other studies, our data show a significantly better outcome in women with non-atypical endometrial hyperplasia by treatment ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01074892?term=AREA%5BBasicSearch%5D(mirena)&rank=5

A Study Comparing Mirena and Systemic Progestin for ... On the other hand a few recent studies have reported successful results after using the LNG-IUD as treatment for endometrial hyperplasia with 100 per cent ...