北京左炔诺孕酮宫内释放系统III期临床试验-曼月乐治疗子宫内膜增生不伴非典型性6个月

登记号	CTR20260808	试验状态	进行中
申请人联系人	临床试验信息公布组	首次公示信息日期	2026-03-05
申请人名称	Bayer Yakuhin, Ltd./ 简柏特（佛山）信息技术服务有限公司/ Bayer Oy

登记号	CTR20260808
相关登记号	暂无
药物名称	左炔诺孕酮宫内释放系统
药物类型	化学药物
临床申请受理号	JXHL2500344
适应症	子宫内膜增生不伴非典型性
试验专业题目	一项评估患有子宫内膜增生不伴非典型性的女性经曼月乐或口服醋酸甲羟孕酮治疗6个月后完全缓解比例的多中心、开放性、随机、平行组研究
试验通俗题目	曼月乐治疗子宫内膜增生不伴非典型性6个月
试验方案编号	22923	方案最新版本号	5.0
版本日期:	2025-10-01	方案是否为联合用药	否

申请人名称	[["Bayer Yakuhin, Ltd."],["简柏特（佛山）信息技术服务有限公司"],["Bayer Oy"]]
联系人姓名	临床试验信息公布组	联系人座机	010-65360866	联系人手机号
联系人Email	clinical-trials-contact@bayer.com	联系人邮政地址	北京市-北京市-北京市朝阳区东大桥路9号北京侨福芳草地大厦D座7层	联系人邮编	100020

主要目的：确定曼月乐治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）； 关键次要目的：1.确定口服醋酸甲羟孕酮治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）；2.确定曼月乐与口服醋酸甲羟孕酮相比治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	女
健康受试者	无
入选标准	[["签署知情同意书时为月经初潮后女性（≥18岁）。"],["经组织学证实为子宫内膜增生不伴非典型性（NAEH）的女性，与其产次或绝经状态无关。"],["接受宫内节育系统（IUS）或口服醋酸甲羟孕酮（MPA）作为NAEH的治疗。"],["年龄21-65岁（含）的受试者的宫颈涂片结果必须为正常或无临床意义（即，无需进一步随访）。筛选访视时的正常结果记录必须是在符合美国阴道镜及宫颈病理学会（ASCCP）指南的频率范围内获得的（Marcus et al 2021）。如果没有符合指南要求的结果，则必须在筛选访视时进行宫颈涂片检查。如果根据中心实验室标准进行的人乳头瘤病毒脱氧核糖核酸（HPV DNA）检测结果为高危型HPV阴性，那么患有非典型鳞状上皮细胞，未明确诊断意义（ASCUS）的受试者可以纳入到该研究中。"],["40-75岁（含）的受试者必须有签署知情同意书前12个月内的正常乳腺影像学检查结果记录。如果没有最近的乳腺影像学检查结果，则受试者必须在随机化前相应接受乳腺筛查（American Cancer Society 2023, USPSTF 2024）。"],["愿意并能够参加计划的研究访视，并遵守研究程序。"],["女性，受试者或受试者伴侣使用的避孕措施应符合当地法规对于参加临床研究的受试者的避孕方法要求。 n- 如果受试者未怀孕，且符合以下条件之一，则有资格参加研究： n- 无生育能力（NCBP）或有生育能力（CBP）并在随访期间使用可接受的避孕方法。 n- CBP受试者在筛选（访视1）时的妊娠试验结果必须为阴性（按当地法规要求进行尿液或血清妊娠试验）。 如果尿妊娠试验无法确认为阴性（例如，结果不明确），需进行血清妊娠试验。在这种情况下，如果血清妊娠试验结果为阳性，则必须将受试者从研究中排除。"],["签署知情同意，包括遵守知情同意书（ICF）和本方案中所列出的要求和限制条件。"]]
排除标准	[["妊娠"],["产后放置研究干预应推迟至子宫完全复旧，且不早于分娩后6周。如果子宫复旧时间严重后推，研究者应考虑等待至产后12周再放置。"],["筛选访视（访视1）前3个月内有产后子宫内膜炎或感染性流产。"],["急性宫颈炎或阴道炎（直至成功治疗）。"],["急性盆腔炎（PID）或PID病史（除非治疗成功）"],["先天性或获得性子宫或宫颈异常，包括纤维肿瘤或宫颈狭窄，研究者认为会干扰宫内节育系统的放置和/或保留（即，如果这些异常情况使宫腔变形）。"],["宫颈肿瘤、子宫或宫颈恶性肿瘤、子宫内膜不典型性增生或性激素依赖性肿瘤。"],["接受抗逆转录病毒治疗后仍未得到良好控制的人类免疫缺陷病毒（HIV）患者（病毒载量可检出，即>200拷贝/mL且CD-4计数为<500个细胞/μL的患者）。"],["根据研究者的评估，在激素干预下可能恶化的任何疾病或状况。"],["可能损害身体系统功能并可能导致研究药物吸收改变、过度蓄积、代谢受损或者排泄改变的任何疾病或状况。"],["可能干扰研究实施或结果解释的任何疾病或状况。"],["计划在研究期间进行研究者认为会干扰研究实施的大手术。"],["对研究干预的任何成分过敏或不耐受。"],["妇科检查的临床相关发现，包括乳房检查/触诊和经阴道超声检查（例如，早孕迹象）。"],["子宫内膜活检诊断为“子宫内膜增生紊乱”。"],["既往诊断为子宫内膜增生不伴非典型性（NAEH）且随机化前24个月内接受过孕激素治疗的受试者。"],["衣原体/淋病检测呈阳性，直至证明已接受适当治疗。"],["在研究开始前60天内发生大量失血（血容量的10%），未进行血容量补充。"],["已知存在具有临床意义的染色体或苗勒管异常。"],["子宫内膜活检结果中记录存在任何形式的非典型性，包括通过筛选宫腔镜检查切除的子宫内膜息肉中存在的非典型增生。"],["受试者已知有子宫癌、卵巢癌或结肠直肠癌遗传易感性（例如林奇综合征）家族史或个人史。"],["任何活动性急性肝病或肝脏肿瘤（良性或恶性）。"],["在研究干预开始前6个月内使用任何长效注射型性激素制剂，和/或在研究干预开始前6周内使用短效激素药物。"],["任何可能具有雌激素或孕酮样活性和/或干扰研究实施或结果的非处方维生素、补充剂和草药治疗（包括中药）。"],["同时参加另一项干预性临床试验。在入组本研究前参加另一项可能影响研究目的的临床试验（根据研究者的判断）。"],["既往已在本研究期间的随机化。"],["随机分组前，根据研究者的评估，安全性相关实验室检查值存在具有临床意义的异常。"],["酒精、毒品或药物滥用（如泻药）。"],["与研究中心存在密切关系，例如，研究者的近亲、相关人员（例如，研究中心的雇员或学生）。"],["出于任何原因不能遵循研究程序，例如：电子日志（eDiary）填写依从性、语言理解、精神疾病、不能到达研究中心"],["非未成年人需要有法定授权代表。"]]

试验药	[["中文通用名:左炔诺孕酮宫内释放系统 英文通用名:Levonorgestrel-releasingintrauterinesystem 商品名称:曼月乐","剂型:宫内释放系统 规格:含左炔诺孕酮52毫克/个 用法用量:最初，左炔诺孕酮以约21微克/天，8年后降至7微克/天。的速率释放（作为宫内节育器）。该速率会逐渐降低，5年后降至约11微克/天，8年后降至7微克/天。 用药时程:6个月"]] 序号 名称 用法
对照药	[["中文通用名:醋酸甲羟孕酮 英文通用名:Medroxyprogesteroneacetate 商品名称:Provera","剂型:片剂 规格:10毫克/片 用法用量:10毫克每日一次 用药时程:6个月"]] 序号 名称 用法

主要终点指标及评价时间	[["确定曼月乐治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）","治疗第6个月","有效性指标"],["确定口服醋酸甲羟孕酮治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）","治疗第6个月","有效性指标"],["确定曼月乐与口服醋酸甲羟孕酮相比治疗子宫内膜增生不伴非典型性的有效性（治疗6个月后子宫内膜增生不伴非典型性的缓解情况）","治疗第6个月","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["评价曼月乐和口服醋酸甲羟孕酮 3个月随访期间子宫内膜增生不伴非典型性的复发或进展情况","治疗6个月后第3个月随访期间","有效性指标"],["评估曼月乐和口服醋酸甲羟孕酮在治疗和3个月随访期间接受子宫切除术的女性比例","治疗期间及3个月的随访","有效性指标"],["在研究结束时（6个月治疗期和随后3个月无治疗期），确定曼月乐和口服醋酸甲羟孕酮治疗子宫内膜增生不伴非典型性的有效性","在研究结束时（6个月治疗期和随后3个月无治疗随访期）","有效性指标"],["评价曼月乐和口服醋酸甲羟孕酮治疗子宫内膜增生不伴非典型性的安全性","治疗期间及3个月的随访","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	朱兰	学位	医学博士	职称	中国科学院院士
	电话	010-69156114	Email	zhu_julie@vip.sina.com	邮政地址	北京市-北京市-西城区大木仓胡同 41 号
	邮编	100032	单位名称	中国医学科学院北京协和医院

[["中国医学科学院北京协和医院","朱兰","中国","北京市","北京市"],["重庆市妇幼保健院","郝丽娟","中国","重庆市","重庆市"],["江西省妇幼保健院","汪利群","中国","江西省","南昌市"],["南京医科大学第二附属医院","王静静","中国","江苏省","南京市"],["青岛市妇女儿童医院","赵淑萍","中国","山东省","青岛市"],["成都市妇女儿童中心医院","何丽","中国","四川省","成都市"],["厦门市妇幼保健院","苏志英","中国","福建省","厦门市"],["浙江大学医学院附属妇产科医院","王悦","中国","浙江省","杭州市"],["南京市妇幼保健院","贾雪梅","中国","江苏省","南京市"],["唐山市妇幼保健院","于艳丽","中国","河北省","唐山市"],["北京中日友好医院","梁海燕","中国","北京市","北京市"],["佛山市妇幼保健院","黄晓斌","中国","广东省","佛山市"],["陕西省人民医院","陈丽宏","中国","陕西省","西安市"],["北京大学深圳医院","李长忠","中国","广东省","深圳市"],["南方医科大学第三附属医院","刘艳","中国","广东省","广州市"],["The Ottawa Hospital, Riverside Campus - Department of Obstetrics, Gynecology and Newborn Care","Sukhbir Singh","加拿大","Ontario","Ottawa"],["Sinai Health System - Obstetrics & Gynaecology, General Obs Gyn","Mara Sobel","加拿大","Ontario","Toronto"],["Centres Investigation Clinique Mauricie","Veronique Babineau","加拿大","Quebec","Trois-Rivieres"],["AMR - Fort Myers, FL","Kevin Fleishman","美国","Florida","Fort Myers"],["Women's Health Alliance of Mobile","Theodore Catranis","美国","Alabama","Mobile"],["Cornerstone Clinic for Women – Aldersgate","Nathan Livers","美国","Arkansas","Little Rock"],["Lyndhurst Clinical Research","Robert Parker","美国","North Carolina","Winston-Salem"],["AIH Research- Broadway","Yvette Poindexter","美国","Texas","Pearland"],["Physician Care Clinical Research LLC | Sarasota, FL","Gregory Michael Swor, MD, FPMRS","美国","Florida","Sarasota"],["Clinical Research Prime","Jeffrey Baker","美国","Idaho","Idaho Falls"],["University Hospitals | UH Cleveland Medical Center - MacDonald Clinical Trials Unit","Angelina Gangestad","美国","Ohio","Mayfield Heights"],["Rosemark Women Care Specialists","Steven Robison","美国","Idaho","Idaho Falls"],["Discovery Clinical Trials - Dallas","A. Jay Staub","美国","Texas","Dallas"],["Axia Women's Health - Anderson Township","Gerard Reilly","美国","Ohio","Cincinnati"],["Southern Clinical Research Associates","Samuel Alexander","美国","Louisiana","Metairie"],["ClinOhio Research Services, LLC. | Columbus, OH","Harold Green","美国","Ohio","Columbus"],["AMR - Mobile, AL","Danilo Herrera","美国","Alabama","Mobile"],["UF Health Women's Specialists - Emerson","Andrew Kaunitz","美国","Florida","Jacksonville"],["Affiliated Clinical Research, Inc. | Las Vegas, NV","Edmond Pack","美国","Nevada","Las Vegas"],["Columbia University Medical Center - Gynecology","Paula Castano","美国","New York","New York"],["Unified Women's Clinical Research - Centre OB/GYN","Ann Collins","美国","North Carolina","Raleigh"],["UC Davis Health Lawrence J Ellison Ambulatory Care Center - OB/GYN","Mitchell Creinin","美国","California","Sacramento"],["UTHealth Womens Research Program | Memorial City","Sandra Hurtado","美国","Texas","Houston"],["Biopharma Informatic - West Houston","Alexandra Pellicena","美国","Texas","Houston"],["Bethesda North Hospital - Gynecology","James Sosnowski","美国","Ohio","Montgomery"],["Bosque Women's Care | Albuquerque, NM","Carrie Swartz","美国","New Mexico","Albuquerque"],["Omni Fertility and Laser Institute","Leonard Weather","美国","Louisiana","Shreveport"],["OB/GYN Associates of Erie","Michael Scutella","美国","Pennsylvania","Erie"],["Montefiore Medical Park - Eastchester - OBGYN","Lance Bruck","美国","New York","Bronx"],["Revive Research Institute - Michigan - Women's Health","Mona Fakih","美国","Michigan","Dearborn Heights"],["Progressive Women's Health Pllc","Asia Sultana Mohsin","美国","Texas","Friendswood"],["Inova Fairfax Hospital - OBGYN","George Maxwell","美国","Virginia","Falls Church"],["Chattanooga Medical Research, LLC. | Chattanooga, TN","Scott Harnsberger","美国","Tennessee","Chattanooga"],["Rutgers Robert Wood Johnson Medical School - OBGYN","Glenmarie Matthews","美国","New Jersey","New Brunswick"],["Office of Dr. Cindy Basinski, LLC","Cindy Basinski","美国","Indiana","Newburgh"],["Sweet Hope Research Specialty, Inc. - Hialeah","Adrian Marimon","美国","Florida","Hialeah"],["Johns Hopkins Outpatient Center - Obstetrics and Gynecology","James Segars","美国","Maryland","Baltimore"],["South Texas Clinical Research","Dina Eftimescu","美国","Texas","Corpus Christi"],["McGill Family Practice","Lorrie McGill","美国","Nebraska","Papillion"],["Hutzel Women’s Hospital","Jay Berman","美国","Michigan","Detroit"],["Paramount Research Solutions | College Park Location","Michelle Evans","美国","Georgia","Atlanta"],["Virginia Women's Health Associates","Camilla Hersh","美国","Virginia","Reston"],["McFarland Clinic - Medical Arts Building - OBGYN","Jack Swanson","美国","Iowa","Ames"],["UVA Health Midlife Health and Gynecologic Specialties Northridge","Linda Duska","美国","Virginia","Charlottesville"],["Emerald Coast Clinical Research","Samuel Wolf","美国","Florida","Panama City"],["St. Dominic's Gynecology/Oncology","Christen Haygood","美国","Mississippi","Jackson"],["Velvet Clinical Research","Jose Medrano","美国","California","Burbank"],["Alliance Clinical West Hills","Naghmeh Khodai","美国","California","West Hills"],["Allen Clinical Research LLC","Gwen Allen","美国","California","Gardena"],["Velocity Clinical Research - Mobile","Amy Mccoy","美国","Alabama","Mobile"],["Velocity Clinical Research - Lafayette","Darrell Robinson","美国","Louisiana","Lafayette"],["Velocity Clinical Research - Phoenix","Charles plimpton","美国","Arizona","Phoenix"],["UAB Medicine Center for Research in Women's Health","Janeen Arbuckle","美国","Alabama","Birmingham"],["North Valley Women's Care","Melissa Austin","美国","Arizona","Glendale"],["Entrust Clinical Research","Peter Khamvongsa","美国","Florida","Palmetto Bay"],["K2 Medical Research - South Orlando","Beatriz Colon","美国","Florida","Orlando"],["USF Health South Tampa Center for Advanced Healthcare - Gynecology","Jewel Brown","美国","Florida","Tampa"],["Paramount Research Solutions-Nashville","Kendra Hayslett","美国","Tennessee","Nashville"],["OB/GYN Department_Comprehensive Women’s Health Center","Jeanelle Sheeder","美国","Colorado","Denver"],["Marchand OB/GYN","Gregory Marchand","美国","Arizona","Mesa"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2025-11-26"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 41 ； 国际: 207 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；