拜耳启动Mirena®（52mg LNG-IUS）治疗非典型子宫内膜增生的III期研究-动脉网

Bayer starts Phase III study with Mirena® (52mg LNG- IUS) for treatment of nonatypical endometrial hyperplasia

拜耳等信源发布 2025-12-02 15:36

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December

十二月

2025

08:30 AM

早上 08:30

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer starts Phase III study with Mirena® (52mg LNG- IUS) for treatment of nonatypical endometrial hyperplasia

拜耳启动Mirena®（52mg LNG-IUS）治疗非典型子宫内膜增生的III期研究

Not intended for U.S. and UK Media

不适用于美国和英国媒体

Summary

摘要

Expansion of robust clinical development program of Bayer’s long-acting reversible intrauterine system Mirena

拜耳长效可逆宫内系统Mirena的稳健临床开发计划的扩展

(52mg LNG-IUS) / Nonatypical endometrial hyperplasia (NAEH) is benign form of endometrium thickening / Number of new cases annually ranges from 121 to 270 per 100.000 women depending on the population.

(52mg LNG-IUS) / 非典型子宫内膜增生 (NAEH) 是一种良性的子宫内膜增厚形式 / 每年新发病例数根据不同人群，每10万名女性中在121至270例之间。

1,2,3

Currently, there are no approved medical treatment options for NAEH / 52mg LNG-IUS is globally available and in more than 120 countries approved in several indications: prevention of pregnancy, heavy menstrual bleeding, endometrial protection during estrogen therapy for menopausal symptoms and for menstrual pain / Reinforcing Bayer’s leading position and commitment to understanding and advancing women’s healthcare in areas of unmet medical need.

目前，尚无获批的NAEH治疗方法 / 52mg LNG-IUS在全球范围内可用，并在120多个国家获批用于多种适应症：预防妊娠、月经过多、绝经症状雌激素治疗期间的子宫内膜保护以及缓解痛经 / 进一步巩固拜耳在满足女性未被满足医疗需求领域的领先地位和对推动女性医疗保健的理解与发展的承诺。

Berlin, December 2, 2025

柏林，2025年12月2日

– Bayer, a global leader in women’s healthcare, announced today the clinical Phase III study SUNFLOWER (

– 拜耳，全球女性医疗保健领域的领导者，今天宣布了临床三期研究SUNFLOWER（

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gical options) with its 52mg levonorgestrel-releasing intrauterine system (LNG-IUS) Mirena

带有其释放52毫克左炔诺孕酮的宫内系统（LNG-IUS）Mirena

. The study will investigate the efficacy and safety of the 52mg LNG-IUS in the treatment of nonatypical endometrial hyperplasia (NAEH) in women.

该研究将调查52毫克LNG-IUS在治疗女性非典型子宫内膜增生（NAEH）中的有效性和安全性。

Nonatypical endometrial hyperplasia (NAEH) is an abnormal thickening of the lining of the uterus, known as endometrium, due to an imbalance between estrogen and progesterone levels. This condition is classified as nonatypical as the cells in the endometrium do not show signs of cancer. It can be silent, or present with heavy or abnormal bleeding, or bleeding after menopause.

非典型子宫内膜增生（NAEH）是由于雌激素和孕激素水平失衡导致的子宫内膜异常增厚。这种状况被归类为非典型，因为子宫内膜中的细胞没有显示出癌症的迹象。它可以是无症状的，或者表现为月经过多或异常出血，或绝经后出血。

If untreated, this condition may lead to uterine cancer. The annual incidence of nonatypical endometrial hyperplasia (NAEH) ranges from 121 to 270 per 100.000 women depending on the geography, age and menopause status. Currently, there are no approved medical treatment options for this condition presenting a high unmet medical need given its potential to progress to an atypical form or even to uterine cancer..

如果不及时治疗，这种情况可能会导致子宫癌。非典型子宫内膜增生（NAEH）的年发病率根据地理位置、年龄和绝经状态的不同，每10万名女性中在121到270例之间。目前，尚无获批的药物治疗方案可用于治疗这种疾病，而由于其有可能进展为典型形式甚至子宫癌，因此存在高度未满足的医疗需求。

“Having a leading position in global women’s health we are committed to advance science focusing on innovative options to address the unmet medical need of women globally. With this new Phase III study, we are now expanding our broad clinical development program for intrauterine systems to be able to support women suffering from nonatypical endometrial hyperplasia with an effective treatment”, said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division..

“在全球女性健康领域占据领先地位的我们，致力于推进科学，专注于创新方案以满足全球女性尚未满足的医疗需求。通过这项新的III期研究，我们正在扩展针对宫内系统的广泛临床开发计划，以便为患有非典型子宫内膜增生的女性提供有效治疗支持。” 拜耳制药部门研发主管克里斯蒂安·罗梅尔博士表示。

About SUNFLOWER study

关于向日葵研究

The Phase III clinical study SUNFLOWER (

第三阶段临床研究 SUNFLOWER (

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gical options) will evaluate the treatment of nonatypical endometrial hyperplasia (NAEH) with 52mg LNG IUS versus Oral Progestin (OP) and aims to enroll 207 patients at about 90 centers in 3 countries. The study is anticipated to take around 1.5 years until completion. Previous studies

逻辑选项）将评估使用52毫克LNG宫内系统与口服孕激素（OP）治疗非典型子宫内膜增生（NAEH）的效果，目标是在3个国家的大约90个中心招募207名患者。预计该研究将在大约1.5年内完成。以前的研究

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that have tested the use of 52mg LNG-IUS for the treatment of this condition indicate good response based on the type of hormone present in the IUS and the direct effect inside the uterus, helping to bring the endometrium back to normal state in most cases. The aim of SUNFLOWER is to assess how 52mg LNG-IUS is treating NAEH in a controlled clinical study..

测试使用52mg LNG-IUS治疗这种情况的研究表明，基于IUS中存在的激素类型和在子宫内的直接作用，效果良好，有助于在大多数情况下使子宫内膜恢复正常状态。SUNFLOWER 的目的是评估 52mg LNG-IUS 在一项受控临床研究中治疗 NAEH 的效果。

About Mirena

关于Mirena

Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus. Mirena is a long-acting reversible contraceptive (LARC) and can be removed at any time by a healthcare provider if a woman’s plans change.

Mirena是一种T形装置，含有52毫克合成左炔诺孕酮。一旦放置在子宫内，它会持续向子宫直接释放少量的左炔诺孕酮。Mirena是一种长效可逆避孕方法（LARC），如果女性的计划发生变化，可以随时由医疗保健提供者取出。

The current approved indications which may vary from country to country are contraception (prevention of pregnancy), idiopathic menorrhagia/ heavy menstrual bleeding (HMB), endometrial protection during estrogen therapy for menopause and dysmenorrhea (painful periods). Mirena is available in more than 120 countries..

目前批准的适应症可能因国家而异，包括避孕（预防怀孕）、特发性月经过多/重度月经出血（HMB）、绝经期雌激素治疗期间的子宫内膜保护以及痛经（月经疼痛）。Mirena已在120多个国家上市。

About Women’s Healthcare at Bayer

关于拜耳的女性医疗保健

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases.

妇女健康深植于拜耳的DNA中。作为全球女性医疗保健的领导者，拜耳长期致力于通过推进一系列创新治疗方法来实现科学改善生活的目标。拜耳提供多种有效的短效和长效避孕方法，以及更年期管理和妇科疾病的治疗方案。

Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives.

拜耳还专注于创新选择，以解决全球女性未满足的医疗需求，并拓宽如更年期等方面的治疗选择。此外，拜耳计划到2030年，通过资助多利益相关方的援助项目来加强能力建设，并确保提供价格合理的现代避孕药具，从而使低收入和中等收入国家每年1亿女性获得计划生育服务。

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations..

这是自2020年以来全面可持续发展措施和承诺的一部分，并与联合国的可持续发展目标相一致。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠性和质量。在2024财年，该集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

在Facebook上关注我们：

http://www.facebook.com/bayer

在LinkedIn上关注我们：

Bayer | Pharmaceuticals

拜耳 | 制药

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司实际的未来结果、财务状况、发展或业绩与这里提供的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任 whatsoever

them to future events or developments.

让他们参与未来的事件或发展。

References

参考文献

：

Ring, K.L., A.M. Mills, and S.C. Modesitt, Endometrial Hyperplasia. Obstet Gynecol, 2022. 140(6): p. 1061-1075.

Ring, K.L., A.M. Mills, 和 S.C. Modesitt，子宫内膜增生。《妇产科学》，2022年，140卷（6期）：第1061-1075页。

Reed SD, Newton KM, Clinton WL, Epplein M, Garcia R, Allison K, Voigt LF, Weiss NS. Incidence of endometrial hyperplasia. Am J Obstet Gynecol. 2009 Jun;200(6):678.e1-6. doi: 10.1016/j.ajog.2009.02.032. Epub 2009 Apr 23. PMID: 19393600; PMCID: PMC2692753.

里德 SD、牛顿 KM、克林顿 WL、埃普斯坦 M、加西亚 R、艾莉森 K、福格特 LF、韦斯 NS。子宫内膜增生的发病率。《美国妇产科杂志》。2009年6月；200（6）：678.e1-6。doi: 10.1016/j.ajog.2009.02.032。电子版发表于2009年4月23日。PMID: 19393600；PMCID: PMC2692753。

Petersdorf K, Groettrup-Wolfers E, Overton PM, Seitz C, Schulze-Rath R. Endometrial hyperplasia in pre-menopausal women: A systematic review of incidence, prevalence, and risk factors. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:158-171. doi: 10.1016/j.ejogrb.2022.02.015. Epub 2022 Feb 17. PMID: 35217456..

Petersdorf K, Groettrup-Wolfers E, Overton PM, Seitz C, Schulze-Rath R. 绝经前女性的子宫内膜增生：发病率、患病率和风险因素的系统评价。《欧洲妇产科与生殖生物学杂志》。2022年4月；271卷：158-171页。doi: 10.1016/j.ejogrb.2022.02.015。2022年2月17日在线发表。PMID: 35217456。

Abu Hashim H, Ghayaty E, El Rakhawy M. Levonorgestrel-releasing intrauterine system vs oral progestins for non-atypical endometrial hyperplasia: a systematic review and metaanalysis of randomized trials. Am J Obstet Gynecol. 2015 Oct;213(4):469-78. doi: 10.1016/j.ajog.2015.03.037. Epub 2015 Mar 19. PMID: 25797236..

Abu Hashim H，Ghayaty E，El Rakhawy M。左炔诺孕酮宫内释放系统与口服孕激素治疗非典型子宫内膜增生：随机试验的系统评价与荟萃分析。《美国妇产科学杂志》。2015年10月；213（4）：469-78。doi: 10.1016/j.ajog.2015.03.037。Epub 2015年3月19日。PMID: 25797236。

Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2. PMID: 32909630; PMCID: PMC8200645.

米特迈尔 T，法兰特 C，怀斯 MR。左炔诺孕酮宫内释放系统治疗子宫内膜增生。科克伦数据库系统综述。2020年9月6日；9（9）：CD012658。doi: 10.1002/14651858.CD012658.pub2。PMID：32909630；PMCID：PMC8200645。

Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037. PMID: 20934679.

Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK。口服孕激素与释放左炔诺孕酮的宫内系统治疗子宫内膜增生：一项系统评价和荟萃分析。《美国妇产科杂志》。2010年12月；203（6）：547.e1-10。doi: 10.1016/j.ajog.2010.07.037。PMID: 20934679。

Contact

联系

Katja Wiggers

卡特娅·维格斯

Women's Healthcare

妇女保健

katja.wiggers@bayer.com

+49 30 221541614

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