A Phase I, Open-label, Randomized, Three-period, Crossover, Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa (Gonal-f) and 450 IU of Lutropin Alfa (Luveris) Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris, Administered SC as Liquid and FD Formulation, in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants

The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the co-administration of Gonal-f and Luveris (Reference), administered subcutaneously (SC) in pituitary suppressed, healthy premenopausal Chinese female participants, at the doses of 900 international unit (IU) of follitropin alfa and 450 IU lutropin alfa.

开始日期2021-05-08

申办/合作机构

Merck Healthcare KGaA

NCT04719000 / Recruiting临床4期IIT

PErsonalized Addition of Recombinant LH in Suboptimal Responders >35 Years Old (POSEIDON Group 2): A Randomized Controlled Trial

Different ovarian stimulation regimens have shown to modify late follicular phase hormonal profiles. Besides, recent studies confirm that progesterone levels and their variation in the last day of oocyte maturation are affected by the dose of gonadotropins administered and by other factors. Progesterone elevation in late follicular phase of in vitro fertilization/intracytoplasmatic sperm injection (IVF/ICSI) cycles under ovarian stimulation compromises implantation rates due to a negative effect on the endometrium. However, there is still conflict in the literature questioning whether progesterone levels alone on the triggering day is a sufficient indicator as progesterone does not give the full picture of the ovarian functions, number of follicles as well as estrogen production that facilitate endometrial growth, thus some studies suggest that especially in aged and poor responders Progesterone/Estrogen (P4/E2) ratio has a better reflection (Progesterone (ng/mL) ×1,000/estradiol(pg/mL)) on the ovarian function.
The scope of the current pilot study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering of women belonging to POSEIDON category group 2 who undergo a new ovarian stimulation with a dose of rhFSH 300 IU or 300 IU rhFSH plus 150 IU recombinant human luteinizing hormone (rhLH) in a gonadotropin-releasing hormone (GnRH) antagonist protocol.

开始日期2021-02-04

申办/合作机构

Merck & Co., Inc.

NCT04385342 / Unknown status临床4期IIT

Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization

The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.

开始日期2020-06-30

申办/合作机构

Mansoura University

100 项与 Follitropin alfa/Lutropin alfa 相关的临床结果

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100 项与 Follitropin alfa/Lutropin alfa 相关的转化医学

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100 项与 Follitropin alfa/Lutropin alfa 相关的专利（医药）

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项与 Follitropin alfa/Lutropin alfa 相关的文献（医药）

2023-03-27·Diagnostics (Basel, Switzerland)

Corifolitropin-Alfa plus Five Days Letrozole Versus Daily Recombinant-FSH in Expected Normo-Responder Patients: A Retrospective Comparative Study.

Article

作者: D'Amato, Giuseppe ; Cicinelli, Ettore ; Cantatore, Clementina ; Vitagliano, Amerigo ; Stanziano, Antonio ; D'Amato, Antonio ; Caringella, Anna Maria

Background: In recent times, different novel GnRH-antagonist protocols with various combinations of gonadotropins and other molecules (e.g., aromatase inhibitors, selective estrogen receptor modulators) have been proposed for expected normal ovarian responders undergoing assisted reproductive treatments. The purpose of this study was to evaluate the effectiveness of a novel ovarian stimulation protocol based on the combination of corifollitropin-alfa plus five days of letrozole in E-NOR women undergoing IVF as compared with a daily recombinant-FSH regimen. Methods: We conducted a retrospective-controlled study on 182 couples undergoing their first IVF attempt. In Group A (experimental), letrozole (2.5 mg daily) was administered from day 2 (up to day 6 of the cycle), followed by corifollitropin-alfa on day 3 and daily recombinant FSH from day 10. In Group B, recombinant FSH from day 2 were administered (150 IU-225 IU daily). Statistical analysis was completed using SPSS Statistics. The primary outcome was the total number of MII oocytes retrieved. Results: Group A showed similar results compared to Group B in terms of MII oocytes, live birth, implantation, and clinical pregnancy rates (p = ns). Nevertheless, the experimental group was associated with a trend towards a higher number of developing follicles, total oocytes, and embryos (p < 0.05) with lower estradiol and progesterone values at ovulation induction compared to Group B, resulting in an increased chance of performing a fresh embryo transfer (p < 0.05). Conclusions: The combination of CFα plus five days of letrozole was associated with a trend towards a higher number of developing follicles, total oocytes, and obtained embryos. Moreover, the experimental protocol resulted in lower estradiol and progesterone values at ovulation induction compared to daily rFSH, with an increased chance of performing a fresh embryo transfer (with no OHSS occurrence). Given the observational design of our study, further well-conducted RCTs are needed.

2021-10-01·Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia

Improving Implantation Rate in 2nd ICSI Cycle through Ovarian Stimulation with FSH and LH in GNRH Antagonist Regimen

Article

作者: Borges, Edson ; Setti, Amanda Souza ; Iaconelli, Assumpto ; Braga, Daniela Paes de Almeida Ferreira

Abstract:

Objective To investigate whether patients with a previous recombinant follicle stimulating hormone (rFSH)-stimulated cycle would have improved outcomes with rFSH + recombinant luteinizing hormone (rLH) stimulation in the following cycle. Methods For the present retrospective case-control study, 228 cycles performed in 114 patients undergoing intracytoplasmic sperm injection (ICSI) between 2015 and 2018 in an in vitro fertilization (IVF) center were evaluated. Controlled ovarian stimulation (COS) was achieved with rFSH (Gonal-f, Serono, Geneva, Switzerland) in the first ICSI cycle (rFSH group), and with rFSH and rLH (Pergoveris, Merck Serono S.p.A, Bari, Italy) in the second cycle (rFSH + rLH group). The ICSI outcomes were compared among the groups. Results Higher estradiol levels, oocyte yield, day-3 high-quality embryos rate and implantation rate, and a lower miscarriage rate were observed in the rFSH + rLH group compared with the rFSH group. In patients < 35 years old, the implantation rate was higher in the rFSH + rLH group compared with the rFSH group. In patients ≥ 35 years old, higher estradiol levels, oocyte yield, day-3 high-quality embryos rate, and implantation rate were observed in the rFSH + rLH group. In patients with ≤ 4 retrieved oocytes, oocyte yield, mature oocytes rate, normal cleavage speed, implantation rate, and miscarriage rate were improved in the rFSH + rLH group. In patients with ≥ 5 retrieved oocytes, higher estradiol levels, oocyte yield, and implantation rate were observed in the rFSH + rLH group. Conclusion Ovarian stimulation with luteinizing hormone (LH) supplementation results in higher implantation rates, independent of maternal age and response to COS when compared with previous cycles stimulated with rFSH only. Improvements were also observed for ICSI outcomes and miscarriage after stratification by age and retrieved oocytes.

2021-05-17·Human reproduction (Oxford, England)1区 · 医学

A large observational data study supporting the PROsPeR score classification in poor ovarian responders according to live birth outcome

1区 · 医学

Article

作者: Avril, C ; Lehert, P ; D’Hooghe, T ; Parinaud, J ; Wainer, R ; Rongières, C ; Porcu, G ; Massin, N ; Sagot, P ; Arvis, P

Abstract:

STUDY QUESTION:

Can the Poor Responder Outcome Prediction (PROsPeR) score identify live birth outcomes in subpopulations of patients with poor ovarian response (POR) defined according to the ESHRE Bologna criteria (female age, anti-Müllerian hormone (AMH), number of oocytes retrieved during the previous cycle (PNO) after treatment with originator recombinant human follitropin alfa?

SUMMARY ANSWER:

The PROsPeR score discriminated the probability of live birth in patients with POR using observational data with fair discrimination (AUC ≅ 70%) and calibration, and the AUC losing less than 5% precision compared with a model developed using the observational data.

WHAT IS KNOWN ALREADY:

Although scoring systems for the likelihood of live birth after ART have been developed, their accuracy may be insufficient, as they have generally been developed in the general population with infertility and were not validated for patients with POR. The PROsPeR score was developed using data from the follitropin alfa (GONAL-f; Merck KGaA, Darmstadt, Germany) arm of the Efficacy and Safety of Pergoveris in Assisted Reproductive Technology (ESPART) randomized controlled trial (RCT) and classifies women with POR as mild, moderate or severe, based upon three variables: female age, serum AMH level and number of oocytes retrieved during the previous cycle (PNO).

STUDY DESIGN, SIZE, DURATION:

The external validation of the PROsPeR score was completed using data derived from eight different centres in France. In addition, the follitropin alfa data from the ESPART RCT, originally used to develop the PROsPeR score, were used as reference cohort. The external validation of the PROsPeR score l was assessed using AUC. A predetermined non-inferiority limit of 0.10 compared with a reference sample and calibration (Hosmer–Lemeshow test) were the two conditions required for evaluation.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

The observational cohort included data from 8085 ART treatment cycles performed with follitropin alfa in patients with POR defined according to the ESHRE Bologna criteria (17.6% of the initial data set). The ESPART cohort included 477 ART treatment cycles with ovarian stimulation performed with follitropin alfa in patients with POR.

MAIN RESULTS AND THE ROLE OF CHANCE:

The external validation of the PROsPeR score to identify subpopulations of women with POR with different live birth outcomes was shown in the observational cohort (AUC = 0.688; 95% CI: 0.662, 0.714) compared with the ESPART cohort (AUC = 0.695; 95% CI: 0.623, 0.767). The AUC difference was −0.0074 (95% CI: −0.083, 0.0689). This provided evidence, with 97.5% one-sided confidence, that there was a maximum estimated loss of 8.4% in discrimination between the observational cohort and the ESPART cohort, which was below the predetermined margin of 10%. The Hosmer–Lemeshow test did not reject the calibration when comparing observed and predicted data (Hosmer–Lemeshow test = 1.266688; P = 0.260).

LIMITATIONS, REASONS FOR CAUTION:

The study was based on secondary use of data that had not been collected specifically for the analysis reported here and the number of characteristics used to classify women with POR was limited to the available data. The data were from a limited number of ART centres in a single country, which may present a bias risk; however, baseline patient data were similar to other POR studies.

WIDER IMPLICATIONS OF THE FINDINGS:

This evaluation of the PROsPeR score using observational data supports the notion that the likelihood of live birth may be calculated with reasonable precision using three readily available pieces of data (female age, serum AMH and PNO). The PROsPeR score has potential to be used to discriminate expected probability of live birth according to the degree of POR (mild, moderate, severe) after treatment with follitropin alfa, enabling comparison of performance at one centre over time and the comparison between centres.

STUDY FUNDING/COMPETING INTEREST(S):

This analysis was funded by Merck KGaA, Darmstadt, Germany. P.L. received grants from Merck KGaA, outside of the submitted work. N.M. reports grants, personal fees and non-financial support from Merck KGaA outside the submitted work. T.D.H. is Vice President and Head of Global Medical Affairs Fertility, Research and Development at Merck KGaA, Darmstadt, Germany. P.A. has received personal fees from Merck KGaA, Darmstadt, Germany, outside the submitted work. C.R. has received grants and personal fees from Gedeon Richter and Merck Serono S.A.S., France, an affiliate of Merck KGaA, Darmstadt, Germany, outside the submitted work. P.S. reports congress support from Merck Serono S.A.S., France (an affiliate of Merck KGaA, Darmstadt, Germany), Gedeon Richter, TEVA and MDS outside the submitted work. C.A., J.P., G.P. and R.W. declare no conflict of interest.

TRIAL REGISTRATION NUMBER:

N/A

项与 Follitropin alfa/Lutropin alfa 相关的新闻（医药）

2024-11-08

·默克Merck

默克亮相第七届中国国际进口博览会，共谋行业发展

2024年11月5日至10日，全球领先的科技公司默克重磅亮相第七届中国国际进口博览会（下称“进博会”），默克中国医药健康全面展示了其在心血管、代谢及内分泌、辅助生殖以及肿瘤领域的全球创新成果，并宣布多项合作计划，围绕患者需求，推动行业生态共赢，践行对中国患者的承诺。聚焦创新药物，服务中国患者默克聚焦优势领域，提供高价值临床药物，以期改善患者生命质量。中国是默克在全球范围内最具战略意义的市场之一。进博会上，默克展示了其在辅助生殖，心血管、代谢及内分泌以及肿瘤领域的创新成果，践行对中国患者的承诺。在孕育生命方面作为全球辅助生殖领域的引领者，已有约500万名新生儿借助默克的治疗药物和技术手段来到了这个世界。默克在中国市场有多款经典辅助生殖产品，并持续加速药物先行准入。2024年10月，默克辅助生殖药物倍果乐®（Pergoveris®）顺利落地粤港澳大湾区，内地患者可与全球同步受益。这是粤港澳大湾区执行“港澳药械通”政策后，首个获批在大湾区医疗机构内进行临床使用的辅助生殖药物，也是全球首个且目前唯一的重组人促卵泡素/重组人促黄体素复方制剂。未来，默克将继续支持政府加快创新药物引入，帮助更多满怀希望的中国家庭孕育生机。在改善生命方面格华止®作为首个应用于临床的二甲双胍原研药品牌，已在全球有超过65年的降糖经验，也是国内外各大权威指南推荐的2型糖尿病一线治疗药物1,2,3。为进一步提升患者获益，默克于格华止®在华上市30周年之际推出升级产品格华止®XR（精简处方），并已于今年8月在中国获批。格华止®XR（精简处方）拥有创新缓释工艺——GSD（GelShield）双相控释技术，体积较先前缩小30%，可提高服药便利性和药物依从性，更好实现药品的疗效。在延长生命方面今年是肿瘤精准治疗药物爱必妥®全球上市的20周年，并将于2025年迎来在中国上市的20岁生日。爱必妥®主要用于治疗RAS野生型转移性结直肠癌、复发和/或转移性头颈部鳞状细胞癌及局部晚期头颈部鳞癌，其已于2019年被纳入国家医保目录，降低了广大患者的经济负担。截至2023年，在中国累计治疗目标肿瘤患者数已突破15万例，奠定了其在精准/规范诊疗领域的权威地位，更通过超过15万患者使用该药物的经历证明了其治疗疗效和安全性。在未来，爱必妥®将继续以患者为中心，拓展和满足未被满足的治疗需求，努力为更多的肿瘤患者和家庭带来治疗的希望。满足患者需求，共建行业生态默克始终围绕患者需求，不仅提供高质量的创新产品和服务，满足中国医疗未尽之需，还希望为中国医疗健康行业带来更多价值，与行业同仁携手合作，共建创新、领先、可持续的医疗生态圈。会上，默克与战略零售合作伙伴国大药房、京东健康携手，进一步整合零售线上线下渠道优势，持续深耕及创新，与零售线上线下平台客户的广阔覆盖面、供应链、医疗健康服务相结合；推动默克在糖尿病领域创新产品“格华止®XR（精简处方）”隆重上市，全面推动患者用药可及、便捷高效用药，惠及更多患者。同时，默克与华润广东医药有限公司在进博会上签署战略合作备忘录，以推动大湾区医药健康产业的共同发展，探索特许药械引进领域的合作，优化市场准入流程。双方将携手整合资源，在遵守相关法规的前提下，提升新药的上市速度，进一步保障市场供应，以更好地满足患者的医疗需求。此次合作标志着双方在推动区域医药创新与发展的重要一步，为大湾区的健康产业注入新的活力。双方在签约仪式上表示，期待通过此次合作，共同为公众健康贡献力量。预防更是慢病管理的关键所在。默克支持多学科专家、学会、基金会并协调行业友商，紧密围绕患者和临床需求，启动“甲状腺健康公益行——共筑公益生态”项目，推动甲状腺疾病的“早筛查、早诊治和终身健康管理”的闭环形成，从源头遏制疾病的发生和发展。在慢病管理模式中，患者的自我管理对治疗结局起到重要作用。默克支持中国红十字基金会启动“共同护航——慢病管理和服务”，借助数字化工具，对基层药师提供专业化培训，强化慢病患者疾病知识教育，激发患者主动参与自我管理，实现患者在院外的规范化管理、建立健康的生活方式，改善患者的治疗获益。此外，在默克的协调下，肿瘤精准/规范诊疗20周年启动仪式顺利举办，汇集中国结直肠癌与头颈肿瘤领域的临床和病理专家，以及基因测序和体外诊断的企业同仁，共同回顾精准/规范诊疗20年的发展历程，围绕肿瘤精准/规范诊疗的话题展开深入讨论，致力于通过跨领域合作及不断探索和创新，为患者带来更精准、更规范的诊疗方案，提升患者福祉。提升疾病认知，打造健康理念作为全球科技领导者，默克始终积极投身数字化转型并将数字化融入医药健康服务。默克深刻洞察“以治疗为中心”向“以健康管理为中心”转型的趋势，聚焦疾病防治关键环节，将数字化创新应用于疾病的早期发现和诊断，推动患者的全周期健康管理，例如：在不收集使用者个人信息的前提下，配合国际甲状腺知识宣传周而推出糖尿病患病风险自测、甲状腺健康自测等多种疾病监测管理工具。糖尿病风险自测二维码甲状腺健康自测二维码要实现疾病的早期防控，患者的疾病意识非常重要。在一些疾病领域，由于患者缺乏正确的认知，导致疾病未能早期发现，错过最佳治疗时机，影响治疗结局。比如，不孕不育症在中国发病率居高不下，中国每6对夫妻就有1对受不孕不育症的困扰。不孕不育症治疗的时间关口非常重要，因此需要患者了解一定的疾病知识，尽早寻求规范治疗。进博会上，医疗卫生专业人士在默克的号召下开展了生殖健康科普活动，提高公众对于不孕不育症的认知，树立正确的诊疗观念，为创建生育友好型社会贡献企业力量。进入中国市场九十余年来，默克始终以患者为中心，提供高质量的创新药物解决日益增长的临床需求，并不断拓展医药健康可及性，为每一个中国人的生活带来积极的改变。未来，默克将持续加码布局中国市场，将更多创新产品和健康解决方案引入中国，进一步加强与政府、医疗机构、本土合作伙伴的紧密合作，提升公众疾病认知，改善药品可及性，助力推动中国医疗卫生事业可持续发展以及“健康中国2030”宏伟蓝图的实现。参考文献 1 中国2型糖尿病防治指南（2020年版）.中华医学会糖尿病学分会. 中华糖尿病杂志 2 Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Clinical Guideline From the American College of Physicians. Ann Intern Med. 2024 May;177(5):658-666. 3 Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S158-S178. 向下滑动查看更多默克是一家全球领先的科技公司，专注于医药健康、生命科学和电子科技三大领域。全球大约63,000名员工服务于默克，通过创造更加愉悦和可持续性的生活方式，为数百万人的生活带来积极的影响。从先进的基因编辑技术和发现治疗具有挑战性疾病的独特方法，到实现设备的智能化——默克无处不在。2023年，默克在65个国家/地区的总销售额达210亿欧元。科学探索和负责任的企业精神一直是默克科技进步的关键，也是默克自1668年以来永葆活力的秘诀。默克家族作为公司的创始者至今仍持有默克大部分的股份，我们在全球都叫“默克”，仅美国和加拿大例外。默克的三大领域：医药健康、生命科学及电子科技在这两个国家分别称之为“EMD Serono”、“MilliporeSigma”和“EMD Electronics”。默克在中国已经有90年发展历史，目前拥有近4,500名员工，在北京、上海、无锡、苏州、南通、香港等地拥有21家注册公司。

上市批准申请上市临床研究

2024-10-09

·默克Merck

默克辅助生殖药物倍果乐®（Pergoveris®）落地粤港澳大湾区

默克辅助生殖药物倍果乐®（Pergoveris®）于日前顺利获批引进粤港澳大湾区中山大学孙逸仙医院，内地患者可全球同步受益于这一全球首个且目前唯一符合FSH: LH（促卵泡素：促黄体素）2:1比例的r-hFSH/ r-hLH（重组人促卵泡素/重组人促黄体素）复方制剂。这是粤港澳大湾区执行“港澳药械通”后，首个获批在大湾区的医疗机构内进行临床使用的辅助生殖药物。全国生殖健康流行病学调查数据显示，2007-2020年间，我国不孕发病率已从12%升至18%，且仍有上升的趋势1。女性正常生育能力的维持，需要LH和FSH协同作用。LH和FSH的产生或作用受损（相对或绝对缺乏）会影响配子生成和性腺类固醇的产生，从而降低女性的生育能力。LH和FSH的缺乏是由于多种内外因素导致促性腺激素生成或作用减少所致。这些疾病通常表现为低E2和低/正常促性腺激素水平，在进行卵巢刺激时需要 FSH 和 LH 联合治疗优化卵巢反应2。多项临床数据显示，倍果乐®（Pergoveris®）相较于r-hFSH单药或尿源性hMG（人绝经期促性腺激素），可改善HH（低促性腺激素性性腺功能减退）人群、低/慢反应人群、低预后人群、因GnRH拮抗剂或激动剂而发生LH短暂性医源性缺乏人群及高龄人群的妊娠结局。3-9 默克中国医药健康辅助生殖事业部负责人吴劲表示：我们很高兴看到倍果乐®（Pergoveris®）落地粤港澳大湾区。孕育生命是默克的目标之一。患者的福祉就是我们努力的方向。怀揣‘成就夫妻，成为父母’的初心，我们将继续积极支持政府加快创新药物的引入，进一步提高药物可及性，帮助更多满怀希望的中国家庭孕育生机。倍果乐®（Pergoveris®）适用于严重缺乏LH和FSH的成年女性，以刺激卵泡发育。倍果乐®（Pergoveris®）在全球逾100个国家/地区获批，迄今已有约65,000新生儿在它的帮助下来到这个世界。参考文献 1.https://news.pku.edu.cn/jxky/c78bac82dc814bb9b095c90c44b56f45.htm 2. Kol. Clin Med Insights Reprod Health. 2014;8:59-64； 3. Carone et al. J Endocrinol Invest. 2012;35:996-1002; 4. Raju et al. Reprod Med Biol. 2012;11(3):129-133; 5. Mignini Renzini et al. J Assist Reprod Genet. 2017;34(12):1645-1651; 6. Chen MJ et al.. Front Endocrinol (Lausanne). 2022 Aug 15;13:931756.; 7. Bühler and Fischer. Gynecol Endocrinol. 2012;28(5):345-50; 8. Bielfeld AP, et al. Reprod Biomed Online. 2023 Nov 12;48(6)103725. ; 9. Fábregues et al. Gynecol Endocrinol. 2013;29(5):430-51. 向下滑动查看更多默克是一家全球领先的科技公司，专注于医药健康、生命科学和电子科技三大领域。全球大约63,000名员工服务于默克，通过创造更加愉悦和可持续性的生活方式，为数百万人的生活带来积极的影响。从先进的基因编辑技术和发现治疗具有挑战性疾病的独特方法，到实现设备的智能化——默克无处不在。2023年，默克在65个国家/地区的总销售额达210亿欧元。科学探索和负责任的企业精神一直是默克科技进步的关键，也是默克自1668年以来永葆活力的秘诀。默克家族作为公司的创始者至今仍持有默克大部分的股份，我们在全球都叫“默克”，仅美国和加拿大例外。默克的三大领域：医药健康、生命科学及电子科技在这两个国家分别称之为“EMD Serono”、“MilliporeSigma”和“EMD Electronics”。默克在中国已经有90年发展历史，目前拥有近4,500名员工，在北京、上海、无锡、苏州、南通、香港等地拥有21家注册公司。

上市批准临床结果

100 项与 Follitropin alfa/Lutropin alfa 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Follitropin alfa/Lutropin alfa	G03GA05	DB00094

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
促卵泡激素缺乏	欧盟	Merck Europe BV	2007-06-25
促卵泡激素缺乏	冰岛	Merck Europe BV	2007-06-25
促卵泡激素缺乏	列支敦士登	Merck Europe BV	2007-06-25
促卵泡激素缺乏	挪威	Merck Europe BV	2007-06-25
促黄体激素缺乏	欧盟	Merck Europe BV	2007-06-25
促黄体激素缺乏	冰岛	Merck Europe BV	2007-06-25
促黄体激素缺乏	列支敦士登	Merck Europe BV	2007-06-25
促黄体激素缺乏	挪威	Merck Europe BV	2007-06-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不孕	临床3期	德国	Merck KGaA	2014-01-31
无排卵	临床1期	德国	Merck KGaA	2015-01-31

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02047227 (ESPART, CTgov)	临床3期	不孕	939	rhLH+r-hCG+lutropin alfa+follitropin alfa+Pergoveris (Pergoveris)	艱鑰齋齋構襯鬱製艱鏇(夢餘夢選構壓鹹築憲憲) = 齋構餘獵積壓獵鬱網獵簾網顧遞餘顧繭淵觸衊 (壓鹽鏇艱窪醖顧齋構鹽, 衊憲壓鏇範鹽範蓋襯鑰 ~ 獵選網壓壓鏇繭醖獵衊) 更多	-	2017-01-24
				GONAL-f (r-hFSH)+r-hCG+r-hFSH (GONAL-f)	艱鑰齋齋構襯鬱製艱鏇(夢餘夢選構壓鹹築憲憲) = 繭糧觸窪糧鹹憲獵願憲簾網顧遞餘顧繭淵觸衊 (壓鹽鏇艱窪醖顧齋構鹽, 鹽鏇廠獵鑰憲壓範艱製 ~ 餘鹹醖蓋網襯鬱鬱衊觸) 更多
NCT02317809 (CTgov)	临床1期	无排卵	34	Liquid pergoveris (First Liquid Pergoveris, Then Freeze-dried Pergoveris)	醖鹹醖淵簾淵蓋鬱夢襯(遞鑰構淵簾餘鹽窪鹽網) = 衊廠憲蓋壓鏇憲窪築蓋膚鏇廠廠膚選蓋鬱鑰觸 (範願夢鹽範繭觸簾淵齋, 繭獵製願壓鬱遞築廠窪 ~ 廠夢醖選餘願衊簾糧襯) 更多	-	2016-12-13
				Liquid pergoveris (First Freeze-dried Pergoveris, Then Liquid Pergoveris)	醖鹹醖淵簾淵蓋鬱夢襯(遞鑰構淵簾餘鹽窪鹽網) = 醖廠鹽衊醖鬱鹹遞獵選膚鏇廠廠膚選蓋鬱鑰觸 (範願夢鹽範繭觸簾淵齋, 願獵醖衊淵餘鑰鹹壓願 ~ 憲構壓網築鬱顧繭積積) 更多
NCT02244866 (Pubmed \| Hum Reprod) 人工标引	N/A	不孕	240	Recombinant follicle-stimulating hormone +recombinant luteinizing hormone	顧願餘鬱範獵選遞顧窪(廠鹹鑰糧齋廠顧鬱製範) = 艱餘糧膚遞鹹壓繭選膚齋鹹鬱願築製夢積鬱鬱 (製淵憲繭鏇範壓鹹夢選 )	积极	2015-05-01
				Gonal-F	顧願餘鬱範獵選遞顧窪(廠鹹鑰糧齋廠顧鬱製範) = 餘鬱觸齋獵築積夢築鏇齋鹹鬱願築製夢積鬱鬱 (製淵憲繭鏇範壓鹹夢選 )
NCT01297465 (PERSIST, CTgov)	临床3期	不孕	202	Recombinant human chorionic gonadotropin (r-hCG)+Gonal-f®+Pergoveris® (Gonal-f® Plus Pergoveris®)	壓蓋鹹簾築壓窪繭糧廠(膚築範築範艱積鬱糧築) = 齋製繭願鏇鑰繭觸糧築淵構構襯顧齋網築糧築 (製鬱積觸願鹽鏇憲衊蓋, 觸觸顧憲製襯遞築襯顧 ~ 製衊齋夢鬱積鹽構廠艱) 更多	-	2014-02-24
				Recombinant human chorionic gonadotropin (r-hCG)+Pergoveris® (Pergoveris®)	壓蓋鹹簾築壓窪繭糧廠(膚築範築範艱積鬱糧築) = 鏇築壓廠製艱構獵網繭淵構構襯顧齋網築糧築 (製鬱積觸願鹽鏇憲衊蓋, 衊鬱蓋壓築鏇鏇選鹹鏇 ~ 襯衊顧憲淵鏇遞簾願積) 更多