To assess the efficacy of clomiphene citrate flare effect in the flexible antagonist protocol versus ultra short flare agonist protocol in diminished ovarian reserve. - NIL

开始日期2025-04-10

申办/合作机构-

CTRI/2025/03/081960

/ Not yet recruitingN/AIIT

A comparative study evaluating theefficacy of Gonadotropin in Conjunction with Clomiphene citrate versus Letrozole in Pregnancy rate in women with Ovulatory dysfunction undergoingintrauterine Insemination: Arandomized control trial. - nil

开始日期2025-03-10

申办/合作机构-

NCT06701071

/ Not yet recruiting临床4期IIT

Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients with Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization or egg freezing. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of eggs retrieved.

开始日期2024-12-01

申办/合作机构

University of Southern California

100 项与枸橼酸氯米芬相关的临床结果

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100 项与枸橼酸氯米芬相关的转化医学

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100 项与枸橼酸氯米芬相关的专利（医药）

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7,116

项与枸橼酸氯米芬相关的文献（医药）

2025-09-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Surface-enhanced Raman spectroscopy facilitates the detection of multiple metabolic modulators

Article

作者: Yang, Tao ; Li, Yuanyuan ; Ma, Yueyue ; Xia, Zhichao ; Zhou, Na ; Luo, Xiaojun ; Shen, Yushi

Metabolic regulators can improve the athletic ability of athletes by regulating body metabolism, but it is not conducive to fair competition, so it is listed as a prohibited substance. At the same time, the State General Administration of Sport ordered major event organizers to test food for food-borne stimulants. Surface-enhanced Raman scattering (SERS) spectroscopy has been widely used because of its excellent sensitivity and strong spectral characteristics. Based on the available information, SERS spectrum data of metabolic regulators in food-related fields were lacking. In this study, we used gold dodecahedron nanoparticles as SERS active substrate and successfully captured the characteristic peaks of 6 metabolic regulatory factors. A low cost and stable SERS detection technique for detecting trimetazidine in milk samples with good recovery rate was proposed. Therefore, this method can not only protect the food safety of large-scale sports events, but also have broad application prospects in the food field.

2025-06-01·OBSTETRICS AND GYNECOLOGY CLINICS OF NORTH AMERICA

Therapeutic Options for Unscheduled Bleeding on Hormonal Contraception

Review

作者: Rault, Lule ; Raidoo, Shandhini

Unscheduled bleeding is a common side effect of hormonal contraceptives, often leading to discontinuation. Comprehensive counseling before starting hormonal methods is crucial for improving user satisfaction. For persistent bleeding, common treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and estrogen alone or with progestin in oral contraceptives. Small studies suggest that doxycycline, mifepristone, tranexamic acid, tamoxifen, ulipristal acetate, and clomiphene citrate may reduce bleeding in various contraceptive users. Mifepristone and tranexamic acid show promise for users of depot medroxyprogesterone acetate, implants, and intrauterine devices. While NSAIDs and combined oral contraceptives are commonly used, alternative therapies offer potential, though evidence remains limited.

2025-05-15·Obstetrics & gynecology science

Executive summary: indonesian guidelines on polycystic ovary syndrome management

Article

作者: Permadi, Wiryawan ; Maidarti, Mila ; Ummah, Nafi'atul ; Harzif, Achmad Kemal ; Shadrina, Amalia

ObjectivePolycystic ovary syndrome (PCOS) is a gynecological, endocrine condition characterized by ovulatory disorders, clinical or biochemical hyperandrogenism, and polycystic ovarian morphology. PCOS has significant metabolic and reproductive implications that affect the quality of life of women. This PCOS guideline summary is based on the Indonesian Reproductive Endocrinology and Fertility Association guidelines for PCOS. This guideline is expected to guide the diagnosis and long-term management of PCOS.MethodsWe searched scientific evidence on the Cochrane and PubMed databases using the keyword “polycystic ovary syndrome”. This evidence was reviewed by experts in the field of obstetrics and gynecology, and recommendations were made based on scientific evidence while considering patient values, costs, and resources.ResultsA total of 127 recommendations and practice points were made regarding the diagnosis and management of PCOS. The levels of available health services and management algorithms for PCOS in Indonesia are also included.ConclusionThe first-line treatment for managing hyperandrogenism and menstrual disorders in patients with PCOS is combined oral contraceptives. The first-line treatment for ovulation induction is letrozole, while clomiphene citrate, metformin, gonadotropins, and ovarian surgery serve as the second-line treatment. The third-line treatments included in vitro fertilization, with or without in vitro maturation.

项与枸橼酸氯米芬相关的新闻（医药）

2025-05-23

·舒泰神

一文读懂少弱精子症药物治疗现状及研发进展

据1995年世界卫生组织人类生殖特别规划署(WHO/HRP)统计显示，全球不孕夫妇已达6000~8000万对"。而后根据弗若斯特沙利文的研究称，全球不孕症患病率从1997年的11.0%上升到了2017年的15.0%，其中中国2017年也达到了15.5%。而男性不育患者中，少弱精子症者占了相当大比例，研究表明男性精液参数异常是导致男性不育的重要原因之一，主要表现为无精、严重少精、少精、畸精或弱精子症，其中少、弱精子症占了 3/4，是引起男性不育的最常见的原因。较精液参数正常者，弱精子症患者的不育风险增加 2~3倍，而少弱精子症患者不育风险增加 5~7 倍。在男性不育症中少精子症和弱精子症是其中两种最常见的病症，这两种病症都可能导致男性不育，它们有其共同之处，但在诊断、病因与治疗中也存在一些不同之处：少精子症定义及流行病学特征少精子症是指射出体外的精液中虽然有精子，但精子总数（或精子浓度）低于正常生育力男性精液检查参考值下限。根据《世界卫生组织人类精液检查与处理实验室手册（第5版）》的参考值，禁欲2~7 d，至少2次精液常规分析提示精液中虽然有精子，但1次射精的精子总数<39×106（或精子浓度<15×106/mL），而精液体积、精子活力、精子正常形态率等正常即可诊断为少精子症。据世界卫生组织（World Health Organization, WHO）报告，约15%的育龄夫妇患有不育症，而发展中国家的某些地区甚至高达30%。过去20年里，欧美发达国家男性的精子浓度以平均每年2.6%的速度下降。一项印度的研究统计了17 979例人群的精液检查结果，显示少精子症的发生率为22%；另一项在瑞士进行的一项全国性横断面调查表明，17%的男性精子浓度低于15×106/mL。弱精子症定义及流行病学特征精液中精子的运动可以分为快速向前运动（a级精子）、缓慢前向运动（b级精子）和非前向运动（c级精子）。《世界卫生组织人类精液检查与处理实验室手册》（第5版）不再区分a级和b级精子，统称为前向运动精子，并将精液中精子前向运动（progressive motility, PR）的百分率低于参考值下限（32%）且其他精液参数参考值在正常范围的病症定义为弱精子症。第5版手册同时给出了精子总活力（即前向运动和非前向运动精子总和）的参考值为40%。一般男性人群中弱精子症的患病率尚不清楚。男性不育或不孕不育夫妇中男性弱精子症的流行病学研究结果报道存在差异，患病率从10%至50%不等。这种差异可能与种族、生活习惯和地理环境等差异有关，也可能与调查人群的选择、调查方法的差异以及不同的诊断标准有关。但总体可以看出，弱精子症是男性不育的重要原因，患病人群庞大，临床上需要积极应对。少、弱精子症病因根据少，弱精子两份诊疗专家共识，少精弱精症病因复杂，可由单个因素或同时多个因素引起，部分病因不明，常见病因包括生殖系统疾病、免疫因素、遗传因素、内分泌因素、环境因素等。弱精子症与少精子症主要不同之处在于：弱精症的常见病因是生殖道感染、精索静脉曲张、射精管不全梗阻等，而少精症的病因还包括环境因素、放化疗后及生殖毒性药物、生活习惯、营养因素等。少、弱精子症治疗少、弱精子症的一般治疗：由于精子活力受生活习惯、环境及精神压力等因素的影响，临床治疗时要指导患者保持良好的生活习惯，禁烟，不过量或过频饮酒，少吃高脂肪食物，控制体重，适度运动，防止睡眠不足、熬夜和过度疲劳，缓解精神压力，避免接触环境中生殖毒性物质等。减肥、戒烟、戒酒、体育锻炼能够改善异常的精子参数、激素水平以及肥胖相关的继发性性腺功能减退症（secondary hypogonadism，SH），有利于不育症和实施辅助生殖技术（assisted reproductive technology，ART）治疗的结局。避免长期环境暴露因素和停用影响生精功能的药物。少精子症的药物治疗：（1）激素治疗①继发性性腺功能减退症：首先单独使用人绒毛膜促性腺激素（human chorionic gonadotropin， hCG）250 IU、每周2次启动，为了达到正常血清睾酮水平，可以高达2000 IU、每周2次；如果刺激精子发生失败，可以联用FSH（75~150 IU，每周3次）。尿液提取FSH、高纯化FSH与基因重组FSH的治疗效果没有差异。SH患者较大的基线睾丸体积与睾丸体积增加值是评价促性腺激素（gonadotrophin， Gn）治疗反应、诱导精子发生的最好预后指标［26-27］（2B）。②同化类固醇激素滥用：首先停用该类药物，一般6~12个月可以改善精子数量和质量；如果没有改善，尝试使用hCG，或者联合FSH和氯米芬的其中一种药物刺激精子发生［28］（2B）。（2）其他药物治疗：药物治疗仍然是治疗不育症的常用手段，最好在启动治疗前找到准确病因并针对病因用药，适用于少精子症、弱精子症、畸形精子症或者同时并存前述几种异常类型的患者。如果准备进行经验性药物治疗，则药物使用时间不应少于3~6个月，覆盖1~2个精子发生周期［6，29］（2B）。①抗氧化剂治疗：能够改善精液参数、降低精子DNA碎片率，对于实施ART周期、生育力低下夫妇的活产率和妊娠率均具有正性影响。少精子症是抗氧化剂治疗的适应证之一，常用药物包括维生素E （100 mg bid/tid，口服）、维生素C （200~300 mg bid/tid，口服）、（乙酰）左旋肉碱（1 g bid/tid，口服）、辅酶Q10 （30~100 mg qd，口服）以及叶酸、锌、硒微量元素等［30-31］（2B）。②选择性雌二醇受体调节剂（selective estrogen receptor modulators，SERMs）：推荐SERMs作为少精子症的一种经验性治疗方式，部分患者可以增加精子总数和精子浓度。常用药物包括氯米芬（25~50 mg/d，口服）和他莫昔芬（10~30 mg/d，口服）［32］（2C）。③芳香化酶抑制剂（aromatase inhibitors，AIs）：甾体类（睾内酯）或非甾体类（阿那曲唑、来曲唑）AIs能够增加内源性睾酮的水平、改善精子发生，显著改善睾丸功能障碍以及血清睾酮水平或睾酮/雌二醇比值降低的不育症男性的激素和精液参数。常用药物为来曲唑2.5 mg/d，口服［33］（2C）。（3）高泌乳素血症：不受病因影响（包括垂体腺瘤）的治疗方法包括多巴胺激动剂治疗（溴隐亭、卡麦角林、喹高利特）或者停用致病药物。常用药物为溴隐亭，2.5~7.5 mg/次，2~4次/d［34］（2C）。弱精子症的药物治疗：病因明确的，针对病因进行治疗。对于特发性弱精子症，选择经验性药物治疗。治疗时间一般以３个月一个治疗周期，治疗过程中需进一步评价治疗的疗效和安全性。1.基础药物治疗：多原因造成的弱精子症中氧化应激反应及其造成的细胞损伤是共同的发病机制，基础治疗中通常包括抗氧化剂。硒元素、联合左卡尼汀和乙酰左卡尼汀、辅酶Q10可以明显改善精子活力等参数，合用锌和叶酸、合用多不饱和脂肪酸EPA（eicosapentaenoic acid，二十碳五烯酸）和DHA（docosahexaenoic acid，二十二碳六烯酸）有助于妊娠率的提高。2.针对病因的药物治疗：（1）抗菌消炎药：明确的男性生殖道或附属性腺感染，应根据其临床症状和细菌学检查确诊，使用敏感的抗生素治疗。（2）内分泌疗法：对于生殖激素异常引起的，可选用促性腺激素、雌激素受体拮抗剂或芳香化酶抑制剂等调节生殖激素的方法。治疗要同时考虑生育结局，鉴于雄激素的使用可能会影响男性患者生精能力，故不推荐使用外源性雄激素治疗弱精子症。（3）改善局部血循环：精索静脉曲张引起的存在局部血循环障碍。拒绝或不适合手术治疗的患者尤其是轻中度精索静脉曲张，可使用七叶皂苷类或黄酮类药物增加血管弹性和张力，改善血循环，改善精子活力。3.中医中药治疗：中医药治疗有效性缺少强有力的循证医学证据，临床上谨慎使用。少弱精子症的治疗一直是男科医生的一大难题，各种经验性、非特异性的治疗方法试图用来提高弱精子症患者的精子参数和生育能力，但是疗效依然差强人意。大多数患者最后都需要求助于体外受精(IVF)或卵细胞胞质内单精子注射(ICSI)技术，而后者昂贵的价格和不可预知的治疗风险仍未得到很好的解决。而单从费用上考虑很多患者不愿意进行辅助生殖，因此，弱精子症的药物治疗需进一步深入的药物研发，从而为广大患者提供更优的药物选择。近年来发现神经生长因子（NGF）不仅对神经系统有作用，而且对生殖系统也有十分重要的作用。基础研究表明，NGF在雄性生殖系统的发育、分化和生理功能方面具有调节作用，还能明显提高精子活力和活率，促进精子生成。STSP-0902 是舒泰神自主研发的对特定位点进行定向改造的重组人神经生长因子 Fc 融合蛋白，能够结合并激活 TrkA 受体通路，发挥生物学效应，临床前实验数据显示，STSP-0902可促进神经生长、精原细胞和睾丸支持细胞增殖，提高少弱精子症小鼠模型的精子数量和精子活力，减少精子畸形率，改善睾丸生精小管变性/萎缩。同时，与野生型人神经生长因子相比，STSP-0902 在临床前研究中表现出注射后疼痛反应减弱，体内半衰期延长的特点。STSP-0902 由公司自主研发，发明专利已在国内和国际进行申请。公司于 2024 年 04 月向国家药品监督管理局提交 STSP-0902 注射液（用于治疗少弱精子症）临床试验申请，于 2024 年 06 月取得临床试验批准。2024 年08 月，完成 Ia 期临床试验的首例受试者给药。近日，舒泰神（北京）生物制药股份有限公司（以下简称“舒泰神”或“公司”）取得 STSP-0902 注射液用于治疗少弱精子症的 Ia 期临床研究总结报告，主要研究结论如下：在健康受试者中，在方案设计的剂量范围内，STSP-0902 注射液单次皮下注射安全性和耐受性良好，基本呈线性药代动力学特征，未报告 ADA 阳性，提示免疫原性风险较低。本试验结果支持 STSP-0902 注射液开展进一步的临床研究。参考文献：中国医师协会生殖医学专业委员会生殖男科学组少精子症诊疗中国专家共识编写组.少精子症诊疗中国专家共识[J].中华生殖与避孕杂志,2021,41(07):586-592.DOI:10.3760/cma.j.cn101441-20210418-00177中国医师协会生殖医学专业委员会生殖男科学组弱精子症诊疗中国专家共识编写组.弱精子症诊疗中国专家共识[J].中华生殖与避孕杂志,2021,41(07):593-599.DOI:10.3760/cma.j.cn101441-20210520-00224潘伯臣,孙莹璞,孙海翔,等. 弱精子症病因及临床诊疗专家共识[J]. 生殖医学杂志,2023,32(2):157-169. DOI:10.3969/j.issn.1004-3845.2023.02.001.【学术】弱精子症的诊治——中华医学会男科学分会作者张培新关于舒泰神：公司以自主知识产权创新药物，特别是生物药物的研发、生产和营销为主要业务，在中国证监会上市公司行业分类中归属于“C27医药制造业”类别。作为创新型生物制药企业，公司的产业链条完整，拥有较为完善的研发、生产、质量管理、营销以及配套体系高新技术企业。公司致力于研发、生产和销售临床需求未被满足的治疗性药物，主要包括蛋白类药物（含治疗性单克隆抗体药物）、化学药物等类别，治疗领域聚焦在感染性疾病、呼吸与重症、自身免疫系统疾病及神经系统疾病治疗药物等领域。公司以“持续创新，提供安全有效的治疗药物，为人类健康做贡献”为使命，秉持“以患者利益为根本，合作竞争，创造价值”的核心价值观。

2024-10-16

·GlobeNewswire-Health Care

KYZATREX® (testosterone undecanoate) CIII Capsules Featured in Research at the Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting

RALEIGH, N.C., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals is pleased to announce that KYZATREX® (testosterone undecanoate) CIII capsules will be highlighted in three research abstracts at the upcoming Sexual Medicine Society of North America (SMSNA) Annual Fall Scientific Meeting taking place from October 17th to 20th in Scottsdale, Arizona. KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The abstracts being presented include: "Combined Clomiphene and High-Dose Oral Testosterone Therapy in Hypogonadal Men: A Case Series" – This study, conducted by Dr. Andrew Sun, Grace Yoon BS, and Jimmy Vo BS, explores the effects of combining clomiphene with high-dose oral testosterone therapy, highlighting a novel approach to optimizing treatment outcomes for hypogonadal men. Dr. Sun will present this abstract."Initiating High-Dose Oral Testosterone Undecanoate Therapy in Hypogonadal Men" – This research, conducted by Dr. Andrew Sun, Jimmy Vo BS, and Grace Yoon BS, focuses on the initiation process for high-dose oral testosterone undecanoate therapy, offering valuable data for clinicians considering this treatment option for men with testosterone deficiency. Dr. Sun will present this abstract."Effects of Oral Testosterone Undecanoate on Semen Parameters in Hypogonadal Men: An Interim Analysis of a Prospective Pilot Study" – Presented by Gal Saffati, this study examines the impact of oral testosterone undecanoate on semen parameters, providing new insights into its effects on fertility in hypogonadal men. “We are proud to see KYZATREX featured in these important studies at the SMSNA Annual Meeting, contributing to a deeper understanding of testosterone therapy and its potential benefits for men with hypogonadism,” said Amit Shah, COO of Marius Pharmaceuticals. “These findings highlight the value of exploring new avenues in oral testosterone treatment.” The SMSNA Annual Fall Scientific Meeting gathers leading experts in sexual medicine, providing a platform for sharing innovative research and best practices. Marius Pharmaceuticals remains committed to advancing the science of testosterone therapy and improving outcomes for patients with testosterone deficiency. About KYZATREX® (testosterone undecanoate)KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX or visit www.kyzatrex.com. About Marius PharmaceuticalsMarius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com. Important Safety Information for KYZATREX® (testosterone undecanoate)UseKYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.Important Safety Information for KYZATREX® (testosterone undecanoate) KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.If your blood pressure cannot be controlled, KYZATREX may need to be stopped.Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age). Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX if your red blood cell count increases.If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.Increased risk of prostate cancer.Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.In large doses, KYZATREX may lower your sperm count.Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).Swelling of your ankles, feet, or body (edema), with or without heart failure.Enlarged or painful breasts.Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above.The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX and all medicines out of the reach of children.See Full Prescribing Information and Medication Guide for KYZATREX. Media Contact: Lilly Washburnlilly@mariuspharma.com

临床结果临床3期

2024-08-23

·ETPharma

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

上市批准

100 项与枸橼酸氯米芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00962	枸橼酸氯米芬	G03GB02	DBSALT000490

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
少精子症	日本	Fuji Pharma Co., Ltd.	2022-03-11
不孕	美国	Sanofi-Aventis U.S. LLC	1967-02-01

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
女性不孕症	临床3期	中国	Ferring Holding SA	2013-10-17
女性不孕症	临床3期	中国	Ferring GmbH	2013-10-17
女性不孕症	临床3期	中国	Ferring Arzneimittel Gmbh	2013-10-17

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临床结果

适应症

分期

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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


NCT05206448 (CLC II, CTgov)	临床4期	多囊卵巢综合征 \| 不孕 \| 无排卵	190	letrozole (Letrozole)	醖鹽積範鑰簾選餘網夢 = 糧窪憲獵齋醖願糧製網壓鬱窪鹽鹹窪膚糧艱衊 (範鹽窪淵餘鏇膚壓膚淵, 繭獵簾網壓簾蓋簾觸鹽 ~ 製醖製築衊製獵夢鹽廠) 更多	-	2025-04-15
				letrozole+Clomiphene citrate (Letrozole + Clomiphene Citrate)	醖鹽積範鑰簾選餘網夢 = 簾襯積鹹蓋襯繭齋壓繭壓鬱窪鹽鹹窪膚糧艱衊 (範鹽窪淵餘鏇膚壓膚淵, 衊衊憲鬱壓餘網積鑰獵 ~ 壓淵簾憲衊壓範夢膚獵) 更多
MP42-04 (AUA2024)	N/A	hypogonadism \| abnormal semen parameters \| varicocele	42	clomiphene citrate (Varicocelectomy only)	窪壓簾窪積憲願願築蓋(齋製遞糧鹽餘觸襯顧構) = Overall pregnancy rates were statistically similar at 53% in the VO group and 56% in the dual therapy group 鏇選製鏇淵醖憲鏇糧顧 (窪淵網醖觸衊窪願淵鑰 )	不佳	2024-05-01
				clomiphene citrate (Clomiphene and varicocelectomy)
NCT00068861 (Pregnancy in Polycystic Ovary Syndrome I (PPCOS I), Pubmed \| Fertil Steril)	临床3期	多囊卵巢综合征 anti-Müllerian hormone (AMH)	333	Clomiphene	壓鹹淵壓襯鏇糧築壓繭(選顧構構鹹繭願築構製) = 窪鏇觸餘鏇構鹽憲蓋選鑰構鏇齋蓋壓壓觸淵壓 (鹽鑰鏇鏇繭窪蓋網鹹淵, 8.3)	-	2024-04-01
				Metformin	壓鹹淵壓襯鏇糧築壓繭(選顧構構鹹繭願築構製) = 顧築壓鹹憲積積願醖憲鑰構鏇齋蓋壓壓觸淵壓 (鹽鑰鏇鏇繭窪蓋網鹹淵, 8.3)
FRI442 (ENDO2023)	N/A	继发性睾丸衰竭	31	Clomiphene citrate	鏇廠壓衊築蓋艱遞醖構(膚遞窪繭積齋壓膚遞鏇) = 遞窪膚構構糧糧觸蓋襯餘夢餘艱範衊窪齋齋積 (製製簾壓觸繭製夢壓艱, 0.4) 更多	积极	2023-10-05
NTR1449 (M-ovin trial, Pubmed \| Hum Reprod)	N/A	-	666	Gonadotrophins	鬱艱築鑰觸遞襯糧遞廠(範網憲網鹽願淵範廠範) = 淵繭壓襯糧糧衊範鏇醖餘製蓋淵鹹獵製簾鹽顧 (憲鬱襯築夢積繭願鏇鏇 ) 更多	-	2023-03-01
				Clomiphene citrate (CC)	鬱艱築鑰觸遞襯糧遞廠(範網憲網鹽願淵範廠範) = 網積顧醖簾壓衊襯醖簾餘製蓋淵鹹獵製簾鹽顧 (憲鬱襯築夢積繭願鏇鏇 ) 更多
PMON78 (ENDO2022)	N/A	性腺机能减退 \| 催乳素瘤	1	Clomiphene citrate 25 mg tablet	醖範淵鏇願鏇蓋選糧顧(窪衊範壓齋淵衊構鏇醖) = 廠獵顧鹽餘餘艱觸餘鑰廠鹹鏇蓋襯選獵壓鬱艱 (築淵構艱構獵網鬱繭築 ) 更多	积极	2022-11-01
				Cabergoline	醖範淵鏇願鏇蓋選糧顧(窪衊範壓齋淵衊構鏇醖) = 繭顧鏇衊鑰艱淵艱願選廠鹹鏇蓋襯選獵壓鬱艱 (築淵構艱構獵網鬱繭築 ) 更多
ODP156 (ENDO2022)	N/A	高甘油三酯血症	-	Clomiphene	鬱顧膚範簾鹽構遞積觸(獵夢淵選襯選構餘積糧) = A 34-year-old woman with a significant history of type II diabetes who recently started taking self-prescribed clomiphene presented with epigastric pain, nausea, and vomiting. Laboratory testing revealed normal lipase (30 U/L, normal range 6-51 U/L), increased serum glucose (268 mg/dL, normal range 60-140 mg/dL), and significant elevated TG level (6576 mg/dL, normal range 0-149 mg/dL). Her TG level was 345 mg/dl five months prior to presentation. Abdominal ultrasonography was revealed with no evidence of gallstones and a heterogenous pancreas. She was treated with an insulin infusion and aggressive fluid resuscitation, and her TG level improved to 255 mg/dL after treatment. Given her recent clomiphene use, the patient was deemed to have developed clomiphene-induced severe hypertriglyceridemia. The patient was advised to stop further clomiphene indefinitely and was discharged with fenofibrate 145mg daily and fish oil i.e. omega-3 fatty acid 4g daily for her hypertriglyceridemia. 醖淵壓襯夢餘糧構齋簾 (衊艱鹹鹹製夢鏇鏇憲衊 )	-	2022-11-01
				Fenofibrate 145mg
AUA2021	N/A	睾丸肿瘤	10	Clomiphene	選觸網壓淵鑰襯遞觸簾(醖齋衊鬱齋襯範築齋糧) = 範壓遞餘獵選齋顧襯餘遞鹽餘夢蓋蓋遞艱餘衊 (淵鹽壓遞鏇鹽積廠積蓋 ) 更多	-	2021-09-01
ENDO2021	N/A	继发性睾丸衰竭	-	Clomiphene Citrate	膚窪襯壓鏇鹽範觸鏇淵(積鏇憲積膚獵齋衊鏇醖) = decreased overall mortality and incidence of polycythemia and osteoporosis 製夢醖獵獵構願糧獵選 (遞糧築製鹽遞選構構餘 )	积极	2021-05-03
				Testosterone Therapy
NCT01718444 (CTgov)	N/A	多囊卵巢综合征 \| 不孕	27	Clomiphene Citrate (Group A (No PIES))	獵醖構憲範蓋範願願夢(顧憲鹽網願遞構廠醖壓) = 夢餘窪願鹹鹽繭醖簾製觸遞鏇網願襯壓範觸製 (構艱壓製衊艱醖淵獵憲, 餘鑰網獵鬱壓顧構醖觸 ~ 蓋獵繭構衊網鏇膚壓築) 更多	-	2020-09-29
				Progestin+Clomiphene Citrate (Group B (PIES Group))	獵醖構憲範蓋範願願夢(顧憲鹽網願遞構廠醖壓) = 鑰積齋蓋繭餘繭繭窪艱觸遞鏇網願襯壓範觸製 (構艱壓製衊艱醖淵獵憲, 鏇構夢窪衊觸餘襯鏇積 ~ 淵淵齋獵鬱網繭壓繭簾) 更多