A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of a Human Menopausal Gonadotropin in the Development of Multiple Follicles, Pregnancy, and Cumulative Live Birth as Part of an Assisted Reproductive Technology (ART) Cycle.

The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.

开始日期2025-11-01

申办/合作机构

Granata Bio, Inc.

NCT06997900

/ Recruiting临床2期

Menopur And Rekovelle Combination Study Version 2.0

The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is:
- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ?
Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes
Participants will:
* Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight
* Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels
* Undergo standard IVF procedures including egg retrieval and embryo assessment

开始日期2025-07-04

申办/合作机构

Clinique Ovo, Inc.

[+1]

ChiCTR2500106228

/ Not yet recruiting临床4期IIT

Use of Dienogest in PPOS Protocol for Ovarian Stimulation in Patients with Ovarian Endometriosis

开始日期2025-05-12

申办/合作机构

四川大学华西第二医院（四川大学华西妇产儿童医院）

100 项与高纯度尿促性素相关的临床结果

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100 项与高纯度尿促性素相关的转化医学

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100 项与高纯度尿促性素相关的专利（医药）

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项与高纯度尿促性素相关的文献（医药）

2025-09-26·MEDICINE

How FSH and LH analogs affect fertility hormone results?

Article

作者: Gonel, Ataman ; Ersoy, Ebru

Infertility is defined as the inability of a couple to achieve pregnancy within a certain period despite regular sexual intercourse. With technological advances, infertility treatments have also advanced, and assisted reproductive technologies have become increasingly widespread. In this study, the potential interference effects of different gonadotropin preparations used during controlled ovarian stimulation in in vitro fertilization treatment on hormone levels were experimentally investigated. The effects of urine-derived (menotropin and urofollitropin) and recombinant (folitropin and folitropin + lutropin) gonadotropin preparations on the hormone levels were evaluated. Interference effects on follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, prolactin, testosterone, thyroid-stimulating hormone, free T3, and free T4 hormone levels were analyzed using immunoassay techniques. The results showed significant deviations, especially in the FSH and LH tests, whereas the interference levels varied among the different preparations. The highest interference was observed in the FSH assays, with deviations reaching up to 292,138%. Significant differences were also observed in estradiol and thyroid hormones (free T3 and free T4). These findings suggest that gonadotropin drugs containing high concentrations of FSH and LH may interfere with routine immunoassay-based hormone tests, leading to errors in clinical interpretation. This study emphasizes the need for careful interpretation of hormone assays in patients undergoing in vitro fertilization treatment, and the importance of considering possible interference effects.

2025-09-01·F&S reports

Impact of gonadotropin selection on risk of ovarian hyperstimulation syndrome in predicted high responders: a Menopur in Gonadotropin-releasing hormone Antagonist Single Embryo Transfer–High Responder trial analysis

Article

作者: Schnorr, John ; Thornton, Kim ; Feinberg, Ronald ; Doody, Kevin ; Miller, Charles ; Daftary, Gaurang S. ; Slater, Cristin ; Doyle, Joseph ; Slater, Cristin C. ; Beltsos, Angeline ; Sharara, Fady ; Forman, Eric ; Arredondo, Francisco ; Foulk, Russell ; DeVane, Gary ; Perloe, Mark ; Orris, John ; Heiser, Patrick W. ; Kelly, Lindsay K. ; Schoolcraft, William ; Pang, Samuel ; Zbella, Edward ; Park, John ; Lalwani, Sasmira ; Jacobs, Michael ; Barmat, Larry ; Karande, Vishvanath ; Yeko, Timothy ; Frattarelli, John ; Boostanfar, Robert ; Foster, Eric D. ; Klein, Nancy ; Crain, Jack ; Shapiro, Bruce ; Schnell, Vicki ; Witz, Craig ; Marrs, Richard

Objective:

To evaluate the risk of ovarian hyperstimulation syndrome (OHSS) with highly purified human menopausal gonadotropin (HP-hMG) or recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in patients predicted to be high responders.

Design:

Post hoc analysis of a randomized, open-label, assessor-blind, parallel-group, noninferiority trial conducted at 31 US fertility centers.

Subjects:

620 women with serum anti-Müllerian hormone (AMH) ≥5 ng/mL.

Intervention:

Controlled ovarian stimulation with HP-hMG or rFSH in a gonadotropin-releasing hormone antagonist assisted reproductive technology cycle. Human chorionic gonadotropin trigger and fresh transfer of a single blastocyst was performed unless ovarian response was excessive; in this case, subjects received gonadotropin-releasing hormone agonist trigger and all embryos were cryopreserved. Subjects could undergo frozen blastocyst transfers within 6 months of randomization.

Main Outcome Measures:

Demographic differences between subjects who developed OHSS and those who did not; incidence of OHSS based on trigger type; interaction between baseline AMH and oocyte yield by treatment group; and OHSS incidence based on number of oocytes retrieved by treatment group.

Results:

Subjects who developed early OHSS were significantly younger, with lower weight and body mass index, shorter duration of infertility, and lower baseline estradiol than those who did not develop early OHSS. Among subjects who developed early OHSS, those treated with rFSH had a lower weight than those treated with HP-hMG; all other baseline demographics were similar between treatment groups. The rate of early OHSS was not significantly different based on trigger type. A statistically significant interaction was observed between baseline AMH and treatment group on the number of oocytes retrieved. Odds of early OHSS increased by 1.06 times (95% confidence interval [CI]: 1.04, 1.08) for each additional oocyte retrieved, independent of treatment group. Subjects with high oocyte yields (>25) had lower early OHSS rates when treated with HP-hMG compared with rFSH (difference: 24%, 95% CI: 8.3, 36.2). Holding the number of oocytes constant, the odds of early OHSS in HP-hMG-treated subjects was 0.46 times (95% CI: 0.26, 0.82) that in rFSH-treated subjects.

Conclusion:

In predicted high-responder patients, HP-hMG stimulation was associated with significantly diminished OHSS rates compared with rFSH, adjusted for oocyte yield.

2025-08-01·F&S science

Laparoscopic ovarian drilling (LOD) versus Step-up gonadotropin therapy in infertile anovulatory PCOS women resistant to sequential letrozole and gonadotropin-based ovulation induction cycles: a randomized controlled trial

Article

作者: Bashir, Khushbu ; Yedlapalli, Srikar ; Kachhawa, Garima ; Upadhyay, Ashish Datt ; Jayraj, Aarthi K ; Mahey, Reeta ; Negi, Ayushi ; Kumari, Archana ; Bhavana, H V

OBJECTIVE:

To study the effect of laparoscopic ovarian drilling (LOD) vs. step-up gonadotropin therapy on follicular response in infertile anovulatory polycystic ovary syndrome (PCOS) women resistant to sequential letrozole + human menopausal gonadotropin (HMG)-based ovulation induction (OVI) cycles DESIGN: Open-labeled, pilot, randomized controlled trial SUBJECTS: Infertile anovulatory PCOS women (diagnosed according to modified Rotterdam criteria), resistant to sequential letrozole 5 mg + HMG-based OVI cycle (no dominant follicle >10 mm after 14 days of stimulation). Other inclusion criteria were: age 19-38 years; body mass index ≤35 kg/m²; patent fallopian tubes documented on either hysterosalpingography/saline infusion sonography or laparoscopy; antimüllerian hormone (AMH) levels >6 ng/mL. Exclusion criteria were AMH ≤6 ng/mL; moderate to severe male factor infertility and endometriosis.

INTERVENTION:

Participants in group 1 (N = 35) underwent LOD, after which OVI cycles were started with letrozole 5 mg from the following menses. Gonadotropin were added in a sequential manner if required as per the follicular response. Women in group 2 (N = 35) were administered injection of HMG (75 IU) from day 2 of menses and dose increments were done from day 9 onward as per response.

MAIN OUTCOME MEASURES:

Primary outcome was follicular response (dominant follicle >16 mm). Secondary objectives were gonadotropin requirement per cycle, duration of stimulation, time to conception (months), clinical pregnancy rate and ongoing pregnancy rate (>12 weeks). The study also compared the effect of LOD on hormonal parameters (AMH, serum testosterone) and metabolic parameters (fasting insulin, fasting blood glucose, lipid profile, homeostasis model assessment of insulin resistance) after 1-2 months of procedure.

RESULTS:

Majority of the study participants (82.85%) belonged to PCOS phenotype A. The baseline clinical, hormonal, and metabolic characteristics and phenotype distribution were comparable in both groups. The follicular response was significantly higher in the LOD group (93.25%; 83/89) compared with step-up gonadotropin group (28.20%; 11/39). With four spontaneous conceptions, the median time to conception in LOD group was 3.9 (0-8.4) months. The clinical pregnancy rate per patient was significantly higher in LOD group [54.28% (19/35)] as compared with step-up gonadotropin group [8.57% (3/35)]. The ongoing pregnancy rate in the LOD group was 45.71% (16/35) vs. 0% (0/35) in the gonadotropin group. There was a significant fall in the AMH levels from 15.2 ± 2.7 ng/mL to 10.2 ± 4.4 ng/mL after LOD. Although statistically insignificant, the levels of luteinizing hormone/follicle-stimulating hormone ratio, testosterone, fasting insulin, fasting glucose and homeostasis model assessment of insulin resistance levels were also lowered.

CONCLUSION:

Laparoscopic ovarian drilling significantly improves the follicular response compared with step-up gonadotropin-based ovulation induction and results in higher clinical and ongoing pregnancy rates along with a significant reduction in gonadotropin requirement. The procedure may be considered for PCOS women resistant to sequential letrozole + HMG-based ovulation induction, especially phenotype A with high AMH and high follicle number per ovary.

项与高纯度尿促性素相关的新闻（医药）

2025-07-21

·FiercePharma

Ferring summons star power to celebrate World IVF Day with firsthand fertility stories

All three of Ferring’s new celebrity partners have firsthand experience with using in vitro fertilization to grow their families, and all expressed the importance of community throughout the process. Real Housewives and Olympians and social media-famous physicians, oh my! Ferring Pharmaceuticals has assembled a roster of familiar faces to boost its community-building efforts around fertility, tied to this week’s World IVF Day.World IVF Day is celebrated every year on July 25 in honor of the day the first baby was born via in vitro fertilization in 1978. The awareness day “reminds us how far fertility care has come and how much further we need to go,” David Powley, Ferring’s vice president of reproductive medicine, said in a Monday announcement.Ahead of this year’s commemoration, Ferring has recruited “Real Housewives of New York City” star Jessel Taank, gold-medal-winning figure skater Tara Lipinski and well-known reproductive endocrinologist Lucky Sekhon, M.D., to continue the company’s work to normalize discussions about infertility by sharing their own experiences with IVF.The starry group will help spotlight Ferring’s “Fertility Out Loud” platform. The site launched in 2021 to offer information about infertility and treatment options, provide helpful resources and share real stories from people at various points on their fertility journeys.All three of Ferring’s new celebrity partners have firsthand experience with using IVF to grow their families, and all expressed in statements the importance of community throughout the process. As Lipinski said, “What helped me most was connecting with others and leaning on trusted resources for comfort and guidance. That kind of perspective, reassurance and encouragement is exactly what Fertility Out Loud provides. While becoming a parent is deeply personal, by sharing our stories, we can help uplift each other.” Ferring is the maker of several fertility-related products, including Menopur and Novarel, used to induce ovulation in women experiencing infertility, and Endometrin, which provides extra progesterone to women undergoing fertility treatments.In the years since launching the unbranded Fertility Out Loud platform, the company has continued to add new resources to the site, like the 2022 introduction of text-message-based access to live fertility coaches and 2023’s debut of a docuseries tracking four couples’ diverse paths to parenthood.Most recently, last summer, Ferring partnered with virtual male fertility clinic Posterity Health to roll out educational information and a confidential digital assessment to help men better understand their own fertility issues and fight stigma in that realm.

2024-06-20

·FiercePharma

Ferring launches online assessment tool, educational platform around male fertility

The overall goal of the initiative is to make the entire fertility journey more equitable for both women and men, which, according to Ferring, may ultimately help “improve drop-out rates, decrease stress, address stigma, reduce unnecessary medical costs and accelerate the path to pregnancy.” Ferring Pharmaceuticals is setting the record straight on fertility issues. Because infertility is often branded largely as a women’s issue, many men may be unaware of their own possible role in the matter and may not undergo testing in a timely manner—even though research has shown that men “substantially” contribute to about half of all cases of infertility. The issue is further compounded by stigma that may make men feel emasculated or embarrassed to be struggling with their fertility. A new initiative from Ferring, however, is aiming to boost awareness and education around male fertility and break down that stigma. According to a company announcement Thursday, the program was launched in partnership with Posterity Health, a virtual care service focused on male reproductive health and is hosted on Ferring’s existing Fertility Out Loud platform, which launched in 2021 to provide support for aspiring parents. The platform’s new addition will specifically target men, to “activate them to learn about their fertility health and how it may impact the couple’s path to parenthood,” according to Ali Castro, senior director of marketing and strategic engagement for Ferring’s reproductive medicine division. To do so, it’ll offer both educational resources and a confidential digital assessment that male partners can use to gain a better idea of their personal reproductive health. The overall goal of the initiative is to make the entire fertility journey more equitable for both women and men, which, according to Ferring, may ultimately help “improve drop-out rates, decrease stress, address stigma, reduce unnecessary medical costs and accelerate the path to pregnancy.” “When a couple is having trouble conceiving, the male partner typically waits 22 months before seeking an evaluation—during this period the female is often receiving unnecessary, and in some cases, invasive care,” Pam Pure, co-founder and CEO of Posterity, said in the announcement. “Working together with Ferring, we have made it easier to complete a male fertility assessment from home. Identifying and addressing male factor issues early in the fertility journey will empower couples to take control of their reproductive health.” Both the new initiative and larger Fertility Out Loud platform are unbranded, hosted on a standalone site with the only mention of Ferring at the bottom of each page. That said, Ferring does offer several fertility-related products, including Menopur and Novarel, both of which are used to induce ovulation in women struggling with infertility, and Endometrin, which provides extra progesterone to women who are undergoing fertility treatments.

2024-01-14

·行舟Drug

最全美、日、欧盟等28国上市药品检索方法汇总

点击上方的行舟Drug ▲ 添加关注二、欧盟28国英文、简称及加入时间奥地利（AUT、 Austria）比利时（BEL、 Belgium ）保加利亚（BUL、 Bulgaria）克罗地亚（CRO、 Croatia）塞浦路斯（CYP、 Cyprus）捷克（CZE、Czech Republic）丹麦（DEN、 Denmark）爱沙尼亚（EST、 Estonia）芬兰（FIN、 Finland）法国（FRA、 France）德国（GER、Germany）英国（GBR、Great Britain）希腊（GRE、Greece）匈牙利（HUN、 Hungary）爱尔兰（IRL、 Ireland ）意大利（ITA、 Italy ）拉脱维亚（LAT、 Latvia）立陶宛（LTU、 Lithuania）卢森堡（LUX、 Luxembourg）马耳他（ MLT、 Malta）荷兰（NED、 Netherlands）波兰（POL、 Poland）葡萄牙（POR、 Portugal）罗马尼亚（ROM、 Romania）斯洛伐克（SVK、 Slovakia）斯洛文尼亚（SLO、 Slovenia）西班牙（ ESP、 Spain）瑞典（SWE、 Sweden ）冰岛（ISL、Iceland EEA）挪威（NOR、Norway EEA）1965年4月8日，法国、联邦德国、意大利、荷兰、比利时和卢森堡6国在比利时首都布鲁塞尔又签署《布鲁塞尔条约》，1967年7月1日，《布鲁塞尔条约》生效，欧共体正式诞生；1973年英国、丹麦和爱尔兰加入欧共体；1981年希腊加入欧共体；1986年葡萄牙和西班牙加入欧共体；1993年11月1日，根据内外发展的需要，欧共体正式易名为欧洲联盟；1995年奥地利、瑞典和芬兰加入欧盟；2004年5月1日，马耳他、塞浦路斯、波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛10国加入欧盟；2007年1月1日，罗马尼亚、保加利亚加入欧盟；2013年7月1日，克罗地亚正式加入欧洲联盟成为第28个成员国。三、检索药品检索首先要获得药品的商品名和活性成分名，其中商品名一般是英文即可，而活性成分名一般为各国相应语言的名称，差别一般较大，有的即使是英文，不同国家可能也会存在微小差异，所以检索时应灵活运用，综合运用检索信息。另外，在品种相应国家的企业官网也有许多信息可供参考。下面先提供三个获得不同国家药品商品名的途径：1、马丁代尔大典（Proprietary Preparations部分）；2、GENERIC DRUGS（http://www.ndrugs.com/）；3、西班牙官网（前提是要在西班牙上市，主要是在欧盟上市国的商品名）；4、Drugs.com（https://www.drugs.com/）；5、进入KEGG DRUG网址http://www.genome.jp/kegg/drug/，输入英文名，也可查询到其它英文名（用的少些，如尿促性素英文为Menotropins，该名在日本就检索不到，输入该网站检索后知在日本名为Human menopausal gonadotrophin）。另外也可在drugfuture上初步了解品种在各国药典的收载情况，没有通用的信息获得方法，应将各种所得信息取并集了解。下面为具体检索方法：（一）美国FDA官网上信息量很大，有Drugs@FDA、橙皮书、BE一致性指南、非活性成分数据库、溶出数据库等等。药品查询常用Drugs@FDA、橙皮书两个数据库。由于美国药品查询网上已有大量分享，在此不再过多赘述。不过注意名称问题，如绒促性素我国数据库翻译是:Chorionic Gonadotrophin，而FDA的则是CHORIONICGONADOTROPIN，所以检索前面的则是无结果，可检索Chorionic获得信息。美国DAILYMED（https://dailymed-nlm-nih-gov.libproxy1.nus.edu.sg/dailymed/）获得说明书信息，不过这个是非官方的数据，如果与FDA的有出入，以FDA的为准。美国处方药数据库（http://www.rxlist.com/script/main/srchcont_rxlist.asp?src）。（二）日本日本对批准药品各种信息公开的程度是很高的。不过药品检索需要有准确的日文名称，下面先介绍几个准确找到日文名称的方法，不过要综合运用，确保名称准确无误：1、有些老的品种可在我国CDE网站的体外溶出信息库里（日本橙溶出曲线数据库的翻译）找到日文名称：2、通过谷粉搜搜（谷歌）：英文名称+日本。这种可信度没有1、4高；3、进入日本雅虎（http://www.yahoo.co.jp/），检索英文名称。该法同2类似；4、进入国立医药品食品卫生研究所提供的JAN（JapaneseAccepted Names）上市药品名网站（http://moldb.nihs.go.jp/jan/），可查询准确的日文名称。获得日文名后，进入http://www.pmda.go.jp/english/index.html点击红色方框：点击红色处方药方框：在上图设定项全部打钩。输入日文一般名，在最下面点击以ヒト下垂体性性腺刺激ホルモン为例检索，得：点击红色方框：有说明书和IF文件，未见申报资料和报告书。不过日本的说明书里一般不包含毒理研究资料，但是在不良反应方面一般是非常全面的。再以リラナフタート为例检索：点击一般名进入：下面的2个红色方框是申报资料和审评报告，里面信息量极大。进入http://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html也可直接查询说明书信息。以アモキシシリン水和物为例检索点击检索：点击红色方框：左下角即为PDF版说明书；进入http://generic.createdb.net/，输入日文名也可查询一些药品价格和说明书信息；另用日文名称在厚生劳动省（http://www.mhlw.go.jp/）、日文文献网站（https://www-jstage-jst-go-jp.libproxy1.nus.edu.sg/browse）等查询相关信息。很多时候可以查询到在某次会议上决定停用某药的信息及原因，或相关合成，制剂资料等（引用蒲公英战友的经验，大家可自行试试）。另PMDA网站上还提供了日本最新版药典，网址为http://jpdb.nihs.go.jp/jp17e/；另日本再评价网址：http://www.fpmaj-saihyoka.com/quality/index.html日本橙皮书网址：http://www.jp-orangebook.gr.jp/english/，1995年4月以后申请的口服固体制剂，申请批准时已按要求进行溶出试验的评价，不再进行单独的质量再评价和橙皮书的收录。进入PMDA网站：http://www.pmda.go.jp/english/index.html：点击红色方框：点击红色方框：有部分药品的英文和日文版审评报告，与其他国家相比，披露信息可以说是最多的。三、检索（续-欧盟1）（按加入欧盟时间顺序）欧盟药品一般有集中审评（CP）和非集中审评（DCP）程序（国家和互认程序），集中审评程序的药品一般在EMA官网查询，比较简单，就不在赘述了。另外，http://www.eudrapharm.eu/eudrapharm/welcome.do?selectedStaticLocale.languageCode=en是EMA2006年12月6日建立的数据，供参考。HMA（http://mri.medagencies.org/Human/）官网收载的是互认程序批准的药品，里面有几乎欧盟28国+3国（冰岛、挪威、列支士敦）的药品直接检索链接。下面先对欧盟28国一一介绍：1、法国一、简介1967年7月1日，法国加入欧共体成员国。语言为法语。logo为：二、检索1、进入法国药品安全局http://www.ansm.sante.fr/，点击红色方框：点击上图的“帮助”以了解本站相关的使用信息。以Ovitrelle为例，检索：点击获得详细信息：有些信息，可自行查看。另进入https://www.vidal.fr/，也可查询法国药品处方等信息。2、德国一、简介1967年7月1日，德国加入欧共体成员国。语言为德语。，logo为二、检索 1、进入德国药品局http://www.pei.de/DE/home/de-node.html，选择英文界面：点击红色方框：点击红色方框：点击红色方框：点击红色方框：点击右下角的红色方框：以Targocid为例检索，点击方框的los：点击红色方框：点击获得SPC和说明书信息。另也可通过https://sunset-clause.dimdi.de/Mustertexte/查询，药品信息：点击红色方框：点击：3.意大利一、简介1967年7月1日，意大利成为首批进入欧共体的6国成员之一，语言为意大利语。，logo为二、检索进入意大利官网http://www.agenziafarmaco.gov.it/点击红色方框进入点击红色方框，进入以Simeticone为例，检索活性成分，未检索到，如下：点击红色方框，输入simeticone，得下图。有PIL、SPC等信息，点击进入查看详细信息。下图蓝色方框，为本品意大利语，重复上面的检索。见下图：有不同剂型的商品名，同马丁代尔大典的基本吻合。如下点进去查找先关信息。另外，点击上图绿色方框的公开数据：点击“药物清单数据”：等等，下面还有一些，不一一列举，根据需要自己查看。4.荷兰一、简介1967年7月1日，荷兰成为首批欧共体成员国之一。语言为荷兰语。，logo为二、检索1、进入荷兰药品评价局http://www.cbg-meb.nl/：点击上面的红色方框，再点击Voor mensen（人用），或者点击下面的2个红色方框，再点击胶囊/片剂形状图标进入以Chorionic Gonadotrophin为例（英文商品名、API名均可），本品在荷兰有多个商品名（Choragon; Ovitrelle; Pregnyl; Profasi），一一检索。以Choragon为例，结果如下：点击红色方框进入，得：获得PDF文件。5、比利时一、简介1967年7月1日，比利时成为首批欧共体成员国之一。比利时是西欧的一个联邦国家，首都为布鲁塞尔，欧盟总部所在地。官方语言为法语、荷兰语和德语。全国划分为法语区、荷兰语区、德语区和布鲁塞尔首都法荷语双语区。，logo为二、检索1、进入比利时药品评价局https://www.fagg-afmps.be/en。红色方框选择语言和下载PIL、SPC。主界面：右边有，点击进入点击选择法语（fr），进入在页面最下方的 CBIP.：网址为：http://www.cbip.be/fr/start。点击搜索英文商品名或活性成分名均可。还以Teicoplanin 为例，点击红色方框：蓝色方框为药品分类，红色方框可下载RCP,图片中语言为法语。6、卢森堡一、简介1967年7月1日，卢森堡成为首批欧共体成员国之一。语言为法语、德语、卢森堡语，大小相当于国内的一个县。，logo为二、检索进入官网：http://www.sante.public.lu/fr/politique-sante/ministere-sante/index.html，无英文界面，选择红色方框，进入，是比利时的药品查询地址？共用的？（百度了一下卢森堡与比利时的关系：以前这两块地方都是卢森堡大公管辖的，而卢森堡大公是由尼德兰国王代领的，所以当时的尼德兰包括现在的荷兰比利时和卢森堡。在1830年到1839年比利时革命期间，比利时从尼德兰独立，而亲比利时的卢森堡西部地区就加入了比利时。所以现在比利时有个省叫做卢森堡。而剩下的半个卢森堡就变成了今天的卢森堡大公国。）三、检索（续-欧盟2）7、英国一、简介1973年，英国加入欧共体成员国。语言为英语。，logo为二、检索进入英国药品安全局https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency：点击下面的红色方框：点击红色方框：点击红色方框，以Senokot为例检索：点击获得PAR报告。点击首图的第一个红色方框：点击：红色方框里检索即可。另还可进入英国CMC网站：http://www.medicines.org.uk/emc/search，以Infacol为例，检索：点击获得SPC、PIL信息。8、丹麦一、简介1973年，丹麦加入欧共体成员国。语言为丹麦语，第二官方语言为英语。，logo为二、检索 1、进入丹麦药品局http://laegemiddelstyrelsen.dk/en/。英文界面比较人性化啊。点击红色方框：点击红色方框获得SPC、PIL：点击下面红色方框：进入得：点击得：http://www.medicinpriser.dk/输入英文查询即可查看价格信息。9、爱尔兰一、简介1973年，爱尔兰加入欧共体成员国。语言为爱尔兰、英语。，logo为二、检索 1、进入爱尔兰药品局http://www.hpra.ie/，药品检索一目了然：但是，点进去老是提醒错误，不清楚什么原因，用下面的红色方框检索以Ovitrelle 为例（与输入CHORIONIC GONADOTROPHIN 检索，结果有所不同，所以检索时，可商品名/一般名同时检索获得综合信息）：红色方框获得信息，蓝色方框显示有8个药品。进入上面的仿制药与替代药方框，点击搜索：在下面点击show products或者加法号点击左边红框：信息很多，有的有PAR，里面可能会提到做BE用的参比制剂。10、希腊一、简介1981年，希腊加入欧共体成员国。语言为希腊语。，logo为二、检索1、进入希腊药品国家组织http://www.eof.gr/web/guest;jsessionid=9ce31d9a855371cd79d58e5f05ae：左上角可选择语言，点击国家处方集：点击红色方框，或者点左侧的search点击红色方框，选英文界面还以OVITRELLE为例，点击进去，有PSC、PIL、PAR、价格等很多信息，但是经国家程序批准的药品，其PDF文件为希腊语。另外，还有一些其他信息，根据需要研究。11、葡萄牙一、简介1986年，葡萄牙加入欧共体。语言为葡萄牙语。,logo为二、检索进入官网：http://www.infarmed.pt/portal/page/portal/INFARMED，选择英文版本：点击左下角进入药品检索：点击红色方框（挺人性化的，还有英文翻译），以Sodium Picosulfate为例搜索，未检索到，以其商品名Fructines，检索得：可见活性成分名为Picossulfato de s骴io ，以该名检索：点详细信息：12、西班牙一、简介1986年，西班牙加入欧共体。语言为西班牙语、英语，全球约有5亿人口说西班牙语。，logo为二、检索进入官网：http://www.msc.es/en/home.htm，红色方框可选择英语，该页面右中位置点击红色方框得：选择人用药品，点击蓝色方框：以Targocid为例，查询：点击方框获得详细信息，其中有一条介绍了该品种在欧盟其它国家上市的商品名称，可与马丁代尔大典配合使用：13、奥地利一、简介1995年，奥地利加入欧盟。语言为德语、英语。，logo为二、检索进入奥地利药品器械局官网http://www.basg.gv.at/en/basg-austrian-federal-office-for-safety-in-health-care/：选择英文页面，点击下面的方框选择英文页面，以Targocid为例检索得：14、瑞典一、简介1995年，瑞典加入欧共体成员国。语言为瑞典语。，logo为二、检索 1、进入瑞典药品局https://lakemedelsverket.se/english/，选择英文界面：以Chorionic Gonadotrophin 为例，本品在瑞典有3个商品名：以Ovitrelle为例检索：点击红色方框或详细信息：由于本品为集中审评的品种，在EMA网站上可以查到相关信息。三、检索（续-欧盟3）15、芬兰一、简介1995年，芬兰加入欧共体成员国。语言为芬兰语、瑞典语。，logo为二、检索1、进入芬兰药品局http://www.fimea.fi/，选择英文界面：点击红色方框得：点击红色方框进入：这个检索界面有点不一样。以Lariam为例检索：点击红色方框获得详细信息：点击方法获得相应信息。也有其他下载SPC和PIL的方法，途径差不多，大家研究下官网即可。16、马耳他一、简介2004年5月1日，马耳他加入欧盟。语言为马耳他语、英语。，logo为二、方法 1、进入马耳他药品局http://www.medicinesauthority.gov.mt/home?l=1（英语）点击方框的高级检索，出现如下界面，有国家/集中程序批准的EXCELL版本药品目录：也可点击直接检索，以Choragon 为例：下载详细信息。页面上也有其他信息，可自行了解。17、塞浦路斯一、简介2004年5月1日，塞浦路斯加入欧盟。语言为希腊语、土耳其语。，logo为二、检索进入官网：http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en?OpenDocument，选择英文界面：点击红色方框：点击红色方框：点击红色方框的链接，界面同希腊的基本一样：以PREGNYL为例：点击获得详细信息。18、波兰一、简介2004年5月1日，波兰加入欧盟。语言为波兰语。，logo为二、检索进入波兰药品注册办公室官网：http://www.urpl.gov.pl/pl，选择英文界面：点击红色方框：以Pregnyl为例，检索：点击获得详细信息：当然，也并不是所有的品种都有这些信息，如采用IR、CEN程序进入波兰的产品可能就没有。另外也可以点击首张图片的绿色方框：点击波兰国旗：点击红色方框：再点击红色方框也可进入检索界面。19、匈牙利一、简介2004年5月1日，匈牙利加入欧盟。语言为匈牙利语。，logo为二、检索进入匈牙利国家药品机构官网：https://www.ogyei.gov.hu/nyitooldal/，选择英文界面，很直观简单有数据库连接：点击：以Choragon为例检索，注意是在红色方框、蓝色方框都可以检索：就是蓝色方框网页有点慢：点击查看详细信息：有的品种还会有PAR，RMP（风险管理计划RiskManagement Plan）另，产品上市状态缩写，与常用的缩写稍有不同（以下为谷歌翻译，基本为原文拷贝过来的）：TK：该产品具有有效的销售许可CTK：是由欧洲药品管理局签发,授权是在所有欧盟成员国有效。TT：制剂的上市许可而被删除。该数据库为5年的筹备之内可以删除，因为他们正在删除中找到5年之内仍然处于流通可能（没有安全原因删除）CTT：一个销售授权的产品，欧洲药品管理局已经取消。该数据库为5年的准备中删除，它们可以被发现，因为它们可能仍然在五年内将其删除的可用（它们已被删除非安全原因）ATT：该产品已为行政原因被删除，因为它改变了名称或注册号。随着筹备工作继续进行，或是交易。PI：平行进口20、捷克一、简介2004年5月1日，捷克加入欧盟。语言为捷克语。，logo为二、检索进入捷克国家药品机构官网：http://www.sukl.cz/，选择英文界面：大方框里有些其它信息，点击里面的小方框：以Espumisan为例：点击方框获得详细信息：有PAR、PIL等信息。21、斯洛伐克一、简介2004年5月1日，斯洛伐克加入欧盟，语言为斯洛伐克语，，logo为二、检索进入斯洛伐克国家药品机构官网：http://www.sukl.sk/,最下角选择英文界面：点击红色方框（蓝色方框里的其它信息可根据需要自行了解），以Choriogonadotropin为例检索活性成分：点击MAH下的许可人，可得该许可人在该国上市的所有药品。点击红色方框，获得详细信息：22、斯洛文尼亚斯洛文尼亚网址不知什么原因，一直进不去。药品检索链接为：http://www.jazmp.si/si/zacetna-stran/seznami/。23、爱沙尼亚一、简介2004年5月1日，爱沙尼亚加入欧盟，语言为爱沙尼亚语，国旗为，logo为二、检索进入爱沙尼亚国家药品局官网：http://www.ravimiamet.ee/，选择英文界面：点击红色方框：以Pregnyl为例检索：点击获得详细信息：24、拉脱维亚一、简介2004年5月1日，拉脱维亚加入欧盟，语言为拉脱维亚语，，logo为二、检索进入拉脱维亚国家药品局官网：https://www.zva.gov.lv/，选择英文界面：点击红色方框：点击红色方框：检索即可，以Bronchipret为例检索：另外，不用选择英文界面，在右侧中部如下：点击红色方框，直接有PNZ的PDF版（2010-今）如下：点击图3下边蓝色方框：是API的拉脱维亚语、拉丁语和英语名称，没有详细信息。25、立陶宛一、简介2004年5月1日，立陶宛加入欧盟，语言为立陶宛语，，logo为二、检索进入立陶宛国家药品管控局官网：http://www.vvkt.lt/，选择英文界面：点击红色方框，以Ovitrelle为例，检索：红色方框为详细信息，蓝色方框为说明；再以Pregnyl为例，检索：点击获得详细信息。另也可直接点击下图方框，不过是立陶宛语界面：26、罗马尼亚一、简介2007年1月1日，罗马尼亚加入欧盟，语言为罗马尼亚语，，logo为二、检索进入罗马尼亚国家药品局官网：http://www.anm.ro/anmdm/en/index.html，选择英文界面：点击红色方框得：蓝色方框为其它一些信息，可自行查看。点击红色方框：以上翻译均为谷歌翻译结果，欢迎了解的老师提供准确的翻译结果。以Ovitrelle为例检索：点击获得详细信息：由于是CP程序，所以点击红色方框，直接连接到EMA官网了；再以Pregnyl为例检索：点击就直接可以下载文件了。27、保加利亚一、简介2007年1月1日，保加利亚加入欧盟，语言为保加利亚语，，logo为二、检索进入保加利亚语国家药品局官网：http://www.bda.bg/，选择英文界面：点击红色方框（上面两个一样）：点击红色方框：点击红色方框：点击红色方框:未见药品检索链接，可按字母点进去查看。28、克罗地亚一、简介2013年7月1日，克罗地亚加入欧盟。语言为克罗地亚语。，Logo为二、检索进入克罗地亚国家药械机构官网：http://www.almp.hr/，选择英文界面：点击右边红色数据库方框：以Ovitrelle为例检索：点击获得详细信息：本品为集中程序通过的药品，有相应链接。再以Simvastatin为例检索：点击获得详细信息。另外在下面红色方框里还有申报程序的简单介绍：四、结束语药品信息检索是一个费时费力的过程，也没有放之四海而皆准的方法，不同国家不同品种都有其特殊性，具体检索时要灵活运用现有检索手段。针对有些信息查询困难的品种，也可通过文献专利、向其他同行请教交流等等其他信息获得渠道，力争获取更全面、准确的数据，为项目的顺利研发做好信息支持。文章信息源于公众号药品研发驿站，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新欢迎订阅+医药大数据|行业动态|政策解读

医药出海

100 项与高纯度尿促性素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02692	高纯度尿促性素	G03GA02	DB00032

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
原发性卵巢功能不全	美国	Ferring Pharmaceuticals, Inc.	2014-02-19
女性不育伴无排卵	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2011-09-13
多囊卵巢综合征	澳大利亚	Ferring Pharmaceuticals Pty Ltd.	2011-09-13
无排卵	美国	Ferring Pharmaceuticals, Inc.	2004-10-29
不孕	美国	Ferring Pharmaceuticals, Inc.	2004-10-29
女性不孕症	美国	Ferring Pharmaceuticals, Inc.	1999-08-27

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
男性不育症	临床3期	比利时	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	捷克	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	丹麦	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	波兰	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	西班牙	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	瑞典	Ferring Pharmaceuticals A/S	2009-07-01
男性不育症	临床3期	土耳其	Ferring Pharmaceuticals A/S	2009-07-01

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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


NCT05103228 (CTgov)	N/A	不孕 \| 卵巢储备减少 \| 卵巢疾病	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	艱鏇鏇醖繭艱鹽願餘衊 = 築簾鹽鹹齋廠鬱遞廠齋繭網夢鬱壓壓廠憲選簾 (蓋窪範顧鹹積膚膚艱窪, 選艱製鏇網構淵願窪鏇 ~ 齋鹽製積衊鹽網網願廠) 更多	-	2024-12-13
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	艱鏇鏇醖繭艱鹽願餘衊 = 積網醖願鹽築範繭獵網繭網夢鬱壓壓廠憲選簾 (蓋窪範顧鹹積膚膚艱窪, 壓膚憲鹹糧築膚簾齋壓 ~ 憲鹹繭構遞製壓廠蓋鬱) 更多
NCT04163458 (CLARA, CTgov)	临床3期	不孕 \| 男性不育症	405	Placebo (for MENOPUR powder and solvent for solution for injection)+MENOPUR (MENOPUR Liquid)	觸糧積憲顧簾選襯願選(顧廠鹹鹽淵鬱鹽窪壓鏇) = 夢選積廠壓襯觸夢選壓鏇廠襯範廠蓋窪蓋窪製 (衊鑰觸觸積製築鹽鏇觸, 5.5) 更多	-	2023-11-07
				Placebo (for MENOPUR solution for injection in pre-filled pen)+MENOPUR powder and solvent for solution for injection, 75 IU (MENOPUR Powder)	觸糧積憲顧簾選襯願選(顧廠鹹鹽淵鬱鹽窪壓鏇) = 鏇襯鑰積觸範餘觸積繭鏇廠襯範廠蓋窪蓋窪製 (衊鑰觸觸積製築鹽鏇觸, 4.2) 更多
NCT02554279 (MEGASET-HR, Pubmed)	临床4期	-	620	Highly purified human menotropin (HP-hMG)	簾觸齋築衊鑰鏇醖窪繭(窪齋築簾齋築鏇築遞製) = 窪顧醖顧鬱醖醖糧選遞蓋憲範醖醖願遞製鏇鑰 (鑰獵鏇範顧蓋範艱遞獵 )	-	2020-12-01
				Recombinant follicle-stimulating hormone (FSH)	簾觸齋築衊鑰鏇醖窪繭(窪齋築簾齋築鏇築遞製) = 憲廠築積構窪獵齋築築蓋憲範醖醖願遞製鏇鑰 (鑰獵鏇範顧蓋範艱遞獵 )
NCT02554279 (MEGASET HR, Pubmed \| Fertil Steril) 人工标引	临床4期	卵巢刺激	619	highly purified human menotropin	蓋蓋築淵鏇艱齋艱積顧(壓壓繭構鹽窪糧鹹憲觸) = 遞網築範衊鬱鹹製蓋顧艱窪壓網憲選鹽築淵夢 (壓鹽鑰餘鏇網觸積膚壓 ) 更多	不佳	2020-08-01
				recombinant follicle-stimulating hormone	蓋蓋築淵鏇艱齋艱積顧(壓壓繭構鹽窪糧鹹憲觸) = 衊鑰選範餘鏇觸膚選襯艱窪壓網憲選鹽築淵夢 (壓鹽鑰餘鏇網觸積膚壓 ) 更多
NCT02554279 (MEGASET-HR \| MEGASET HR, CTgov)	临床4期	不孕	620	menotropin (Menotropin)	艱憲製鹹齋鹹顧觸餘膚 = 鹽範淵蓋艱選觸鏇鬱築廠壓鏇鹽選壓鬱鑰鹽膚 (餘壓鬱顧糧醖願願夢選, 鹹鹽鏇艱糧簾鏇構簾遞 ~ 範範獵願窪遞憲鑰醖鹽) 更多	-	2018-03-02
				recombinant FSH (Recombinant FSH)	艱憲製鹹齋鹹顧觸餘膚 = 範範廠衊艱願網簾簾夢廠壓鏇鹽選壓鬱鑰鹽膚 (餘壓鬱顧糧醖願願夢選, 網窪淵鹹淵網襯蓋觸襯 ~ 淵蓋窪壓憲憲憲選顧範) 更多
NCT01921166 (Diminished Ovarian Reserve, CTgov)	临床4期	不孕	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	襯廠製餘醖鏇壓齋醖膚 = 築衊蓋壓窪願鹹製遞範廠壓壓艱淵鏇製淵鑰餘 (窪憲鑰膚膚餘餘鬱鑰淵, 衊淵糧網積醖餘膚鏇夢 ~ 鏇夢蓋壓齋壓窪鬱齋糧) 更多	-	2018-02-23
				Leuprolide flare (Leuprolide Flare)	襯廠製餘醖鏇壓齋醖膚 = 鬱選鹽鹹壓顧選淵鹹繭廠壓壓艱淵鏇製淵鑰餘 (窪憲鑰膚膚餘餘鬱鑰淵, 蓋繭鏇網願鏇窪夢鹹觸 ~ 壓鑰獵繭觸糧鑰夢構選) 更多
NCT02542280 (CTgov)	临床3期	不孕 \| 子宫内膜炎	360	endometrial injury. (Endometrial Injury)	鹽獵繭窪夢艱膚淵艱獵 = 遞積遞糧網糧憲壓廠壓廠餘製淵膚餘鹹夢鹽壓 (齋鹹製築範淵構鏇構夢, 襯壓餘積糧壓願鹽餘淵 ~ 艱憲壓鏇繭顧選鬱廠憲) 更多	-	2016-01-08
				ovarian stimulation (no Endometrial Injury)	鹽獵繭窪夢艱膚淵艱獵 = 夢鏇鬱壓醖選糧艱網築廠餘製淵膚餘鹹夢鹽壓 (齋鹹製築範淵構鏇構夢, 製襯築鏇窪構築製鏇鑰 ~ 窪積醖蓋願簾鏇窪蓋壓) 更多
NCT01569945 (Pubmed \| Hum Reprod)	N/A	不孕	657	Low-dose human menopausal gonadotrophin	鬱鑰憲糧餘膚簾夢膚窪(範製選蓋膚範鏇膚醖遞) = 選構構觸襯淵鏇襯餘構顧齋網積廠壓構築鬱簾 (憲鹹簾製鏇鏇築餘窪鬱 ) 更多	-	2015-05-01
				Clomiphene citrate	鬱鑰憲糧餘膚簾夢膚窪(範製選蓋膚範鏇膚醖遞) = 觸鏇顧窪齋襯構構窪蓋顧齋網積廠壓構築鬱簾 (憲鹹簾製鏇鏇築餘窪鬱 ) 更多
NCT01312766 (CTgov)	临床3期	不孕	270	Menotropins (hMG-IBSA)	膚選繭鏇夢艱餘鏇簾鬱(餘築鑰顧繭鑰餘遞衊淵) = 獵淵觸壓簾選廠鬱壓糧顧淵製鏇蓋獵襯醖夢積 (憲壓鹽夢壓願製蓋遞醖, 6.6) 更多	-	2014-08-15
				Menotropins (Menopur)	膚選繭鏇夢艱餘鏇簾鬱(餘築鑰顧繭鑰餘遞衊淵) = 顧遞觸鬱艱夢鹽鹽淵憲顧淵製鏇蓋獵襯醖夢積 (憲壓鹽夢壓願製蓋遞醖, 5.9) 更多
NCT01417195 (COMBINE, CTgov)	临床4期	不孕	122	Bravelle+Menopur (Menopur and Bravelle Combination)	壓艱襯築夢鑰艱顧觸積(鹹構淵窪鏇積襯鹽鏇壓) = 鹹顧鬱廠襯選顧製蓋壓構蓋餘襯醖憲壓衊蓋鑰 (膚壓糧醖膚襯遞齋願膚, 21.567) 更多	-	2014-04-24
				Menopur (Menopur Alone)	壓艱襯築夢鑰艱顧觸積(鹹構淵窪鏇積襯鹽鏇壓) = 繭鬱膚襯觸衊醖齋壓鑰構蓋餘襯醖憲壓衊蓋鑰 (膚壓糧醖膚襯遞齋願膚, 22.460) 更多