The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:
Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?
Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.
Participants will:
Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger
- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing

开始日期2024-10-01

申办/合作机构

Benha University

NCT06345586 / RecruitingN/AIIT

Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery

开始日期2024-04-18

申办/合作机构

University of Chulalongkorn

NCT06345560 / Recruiting临床1/2期IIT

Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption

开始日期2024-04-18

申办/合作机构

University of Chulalongkorn

100 项与屈螺酮相关的临床结果

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100 项与屈螺酮相关的转化医学

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100 项与屈螺酮相关的专利（医药）

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项与屈螺酮相关的文献（医药）

2024-12-31·Gynecological Endocrinology

The drospirenone only pill as a contraceptive option for breastfeeding women: First data on users’ acceptability and newborn development

Article

作者: Colli, Enrico ; Jakimiuk, Artur ; Regidor, Pedro Antonio

BACKGROUNDProgestin-only pills (POPs) have been used for contraception in breastfeeding women for years. The existing guidelines allow the use of these contraceptives.METHODSMulticenter study with a single visit and retrospective data review. The study involved 100 women who used a drospirenone-only pill (DRSP) for contraception for at least 5 months during breastfeeding. The study aimed to analyze for those successful users the impact on new-born development, the bleeding profile and evaluate user satisfaction.RESULTSAnalysis of the newborns showed that their growth parameters length and weight, were within the expected range of standard development. The mean birth weight was 3368 g, with the lowest recorded weight being 2860 g and the highest 5040 g. The median length of the newborns was 55 cm, ranging from 35 to 65 cm. All new-borns demonstrated appropriate growth within the established percentiles. Acceptability with the bleeding profile was rated with a VAS score: the mean acceptability rating was 82.8. Women aged 35 years or older reported significantly higher acceptability compared to younger women (≥35 years: mean = 88.4, SD = 16.5; <35 years: mean = 80.3, SD = 20.2) (p = 0.02). Sixty-one patients (N = 61; 61.0%; 95% CI: 50.7 - 70.4%) expressed willingness to continue using DRSP after breastfeeding.CONCLUSIONAmong those patients who continued the use of the DRSP only-pill for 5 months, this study shows no negative impact for new-borns, with no clinical influence observed on their growth. Additionally, those users expressed high satisfaction with the bleeding profile of the pill.Clinical trial registration number: DRKS00028438 .

2024-11-01·Fertility and Sterility

Efficacy and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: A multicenter, placebo-controlled, double-blind, randomized study.

Article

作者: Mochiyama, Takayuki ; Takayanagi, Toshiaki ; Nogami, Masayoshi ; Kobayashi, Takao ; Tayzar, Kyaw ; Harada, Tasuku ; Hirayama, Masashi ; Hirakawa, Akihiro ; Foidart, Jean-Michel ; Osuga, Yutaka

OBJECTIVETo evaluate the efficacy and safety of the estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg combination in a cyclic regimen in Japanese women with primary and secondary dysmenorrhea.DESIGNA 16-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study, followed by a 36-week, open-label, extension study.SUBJECTS162 Japanese women with primary and secondary dysmenorrhea.INTERVENTIONParticipants were randomly allocated to either the E4/DRSP group or the placebo group. In the E4/DRSP group, participants orally received one tablet containing E4 15 mg and DRSP 3 mg daily for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. The placebo group was given one placebo tablet daily for 28 days. After 16 weeks, participants in the placebo group were switched to receive E4/DRSP for 36 weeks.MAIN OUTCOME MEASURESAbsolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period.RESULTSE4/DRSP reduced the most severe total dysmenorrhea score by 2.3 points from baseline at week 16. The between-group difference was significant (-1.4, two-sided 95% confidence interval: -1.8 to -1.0), showing superiority to placebo (p<0.001). The responder rate, the proportion of participants who achieved a ≥2.0-point reduction in the most severe total dysmenorrhea score from baseline, was 64.3% in the E4/DRSP group, significantly higher than in the placebo group, 28.4%, (p<0.05). In the E4/DRSP group, visual analog scale scores for pelvic pain and dysmenorrhea symptoms during the menstrual bleeding periods were decreased by 44.2 mm and 42.3 mm, respectively, from baseline at week 16, significantly more than in the placebo group (p<0.001). Objective gynecological examinations suggested amelioration of pelvic tenderness, uterine mobility, and cul-de sac induration in the E4/DRSP group. E4/DRSP improved the quality of life-related questionnaires (interference with daily activities and sleeping) and global impression scores. Intermenstrual bleeding was the primary treatment-emergent adverse event in the E4/DRSP group, similar to combined oral contraceptives. There were no cases of venous thromboembolism and less impact on hemostasis parameters in the E4/DRSP group.CONCLUSIONE4/DRSP is an effective treatment for dysmenorrhea, offering a safe, new treatment option with potentially reduced thromboembolic risk.

2024-11-01·Molecular Neurobiology

A Multistep In Silico Approach Identifies Potential Glioblastoma Drug Candidates via Inclusive Molecular Targeting of Glioblastoma Stem Cells

Article

作者: Kumar, Ashok ; Dogra, Nilambra ; Singh, Parminder

Glioblastoma (GBM) is the highest grade of glioma for which no effective therapy is currently available. Despite extensive research in diagnosis and therapy, there has been no significant improvement in GBM outcomes, with a median overall survival continuing at a dismal 15-18 months. In recent times, glioblastoma stem cells (GSCs) have been identified as crucial drivers of treatment resistance and tumor recurrence, and GBM therapies targeting GSCs are expected to improve patient outcomes. We used a multistep in silico screening strategy to identify repurposed candidate drugs against selected therapeutic molecular targets in GBM with potential to concomitantly target GSCs. Common differentially expressed genes (DEGs) were identified through analysis of multiple GBM and GSC datasets from the Gene Expression Omnibus (GEO) and The Cancer Genome Atlas (TCGA). For identification of target genes, we selected the genes with most significant effect on overall patient survival. The relative mRNA and protein expression of the selected genes in TCGA control versus GBM samples was also validated and their cancer dependency scores were assessed. Drugs targeting these genes and their corresponding proteins were identified from LINCS database using Connectivity Map (CMap) portal and by in silico molecular docking against each individual target using FDA-approved drug library from the DrugBank database, respectively. The molecules thus obtained were further evaluated for their ability to cross blood brain barrier (BBB) and their likelihood of resulting in drug resistance by acting as p-glycoprotein (p-Gp) substrates. The growth inhibitory effect of these final shortlisted compounds was examined on a panel of GBM cell lines and compared with temozolomide through the drug sensitivity EC50 values and AUC from the PRISM Repurposing Secondary Screen, and the IC50 values were obtained from GDSC portal. We identified RPA3, PSMA2, PSMC2, BLVRA, and HUS1 as molecular targets in GBM including GSCs with significant impact on patient survival. Our results show GSK-2126458/omipalisib, linifanib, drospirenone, eltrombopag, nilotinib, and PD198306 as candidate drugs which can be further evaluated for their anti-tumor potential against GBM. Through this work, we identified repurposed candidate therapeutics against GBM utilizing a GSC inclusive targeting approach, which demonstrated high in vitro efficacy and can prospectively evade drug resistance. These drugs have the potential to be developed as individual or combination therapy to improve GBM outcomes.

项与屈螺酮相关的新闻（医药）

2024-11-11

·CPHI制药在线

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2024-10-29

·凯莱英Asymchem

【行研】“生命之钥”——甾体药物

目前全球生产的甾体类药物已超过400种，是仅次于抗生素的第二大类药物，其中最主要的是甾体激素类药物，主要包括性激素、肾上腺皮质激素和其他类。根据溢多利2018年度报告统计显示，自二十世纪九十年代以来，国际市场甾体激素药物销售额每年以10%-15%的速度递增。目前，我国已经把甾体激素药物新资源开发作为医药行业近期发展的方向和重点之一，激素类原料药和中间体的出口也已成为我国原料药走向世界的重要品种。表1. 甾体药物分类来源：太平洋证券，凯莱英整理由于甾体药物产业链较长，根据甾体药物生产厂商的产品所处产业链的不同位置可以将产品分为起始物料、中间体、原料药及制剂。上游是起始物料以植物提取行业为主，从禾本科植物提取植物甾醇；产业链中游包括甾体药物原料加工(雄烯二酮、雄二烯二酮、9-羟基雄烯二酮等)、甾体药物原料药生产和甾体药物中间体生产；产业链下游是甾体药物制剂、销售渠道及终端患者。图1.甾体激素药产业链来源：根据公开资料整理甾体药物在维持生命、调解性功能、机体发育、免疫调解、皮肤疾病治疗及生育控制方面具有明确的作用，近年来市场规模持续增长。根据共研网数据，全球甾体药物市场规模由2011年的640亿美元增长至2021年的1475亿美元，年复合增速为8.71%。中国甾体药物市场规模由2011年的280亿美元增长至2021年的879亿美元，年复合增速为12.12%，2022年约为936亿美元，同比增长6.48%。中国甾体药物市场规模占全球的比重从2011年的44%增长至2021年的60%。下游甾体药物销售规模的增加趋势必然将提升中上游甾体药物原料、中间体及原料药企业市场销售规模。预计未来整个甾体药物行业将处于景气状态，其市场规模也将进一步扩大。图2.全球甾体药物市场规模（亿美元）来源：太平洋证券，凯莱英整理图3.中国甾体药物市场规模（亿美元）来源：太平洋证券，凯莱英整理甾体药物国际主要生产厂家为少数大型跨国制药公司，包括辉瑞、拜耳、默沙东、赛诺菲-安万特等。由于环保成本上升及我国具有原材料优势等多种因素，全球甾体药物生产出现了产业转移的趋势。近年来，由于我国原材料优势明显、生产工艺不断提升，已逐步成为世界甾体药物原料药生产中心。甾体原料药在全球消耗量持续增长，数据显示，2016-2021年全球皮质甾体激素类原料药消耗量呈现持续增长态势，至2021年达到387.58吨，CAGR为12.25%；性激素原料药消耗量增长快于皮质激素，2021年全球性激素原料药消耗量达到489.4吨，CAGR为45.05%。而目前我国甾体激素原料药年产量已占世界总产量的1/3左右，其中皮质激素原料药生产能力和实际产量均居世界第一位，2016年至今初皮质激素、性激素、孕激素和其他激素原料药的年均出口规模分别为 30000万美元、8000万美元、15000万美元。图4.全球皮质激素和性激素甾体原料药消耗量（吨）来源：华经产业研究院，凯莱英整理从具体品种来看，2021年全球皮质甾体激素类原料药消耗量387.58吨，相较于2016年增长率达12.25%。其中，泼尼松龙、氢化可的松、泼尼松全球原料药消耗量位列三甲，消耗量分别为111.49吨、71.25吨、51.60吨，市场占有率达60.5%；布地奈德、氟替卡松、糠酸氟替卡松为下游制剂全球销售额TOP3活性成分，2021年相应下游制剂全球销售额分别为96.84亿美元、82.83亿美元、78.61亿美元。 2021年全球性激素（甾体)原料药消耗量达到489.40吨，比2016年增长45.05%。其中，黄体酮、睾酮、甲地孕酮在全球原料药消耗量位列三甲，消耗量分别为330.37吨、32.36吨、27.27吨，市场份额总计79.69%；炔雌醇、雌二醇、屈螺酮为下游制剂全球销售额TOP3活性成分，2021年相应下游制剂全球销售额分别为30.04亿美元、17.83亿美元、17.48亿美元。图5.全球皮质甾体激素原料药年消耗量TOP10 来源：药招会，公开资料整理图6.全球性激素（甾体）原料药消耗量TOP10 来源：药招会，公开资料整理甾体药物下游制剂市场受疫情负面影响后又回暖。据统计，中国皮质甾体激素药品市场2016-2019年呈现持续增长态势，CAGR为34.61%，至2019年达到195亿元人民币，2020年受疫情影响，市场规模整体萎缩，2021年回暖至190亿元；性激素药物市场，2016-2019年呈现持续增长态势，CAGR为34.18%，至2019年达到84.21亿元人民币，2020年受疫情影响，市场规模整体萎缩，2021年回暖至96.61亿元。图7.国内皮质激素、性激素甾体制剂销售额（亿元）来源：根据公开资料整理总体来看，国内甾体制备技术的转型起步较晚，我国甾体药物相关产品生产厂商主要布局在中低档产品，国内可生产的高档产品品种较少。二十一世纪初受制于双烯价格居高不下，原料药厂商逐渐转向生物技术路线，相比传统工艺技术，生物技术路线具备成本低、污染少、产能高等三大优势，技术革新为国内甾体药物产业的良性发展提供了新动力。 References 参考文献 1.《聚焦甾体药物领域，产品向下游延展打开成长空间》，太平洋证券，2024.4 2.《原料药行业量升价稳，拐点将至》，开源证券，2024.4

2024-06-12

·Pharmaceutical Technology

Bankrupt Mithra cashes in on remaining assets for $188.2m

Mithra’s efforts to extend its cash runway earlier this year were unsuccessful. Image credit: Shutterstock/Nudphon Phuengsuwan. A day after filing for bankruptcy, Mithra has sold its share in two of its daughter pharmaceutical companies along with rights to its female hormone drug portfolio for €175m ($188.2m). Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry The deal saw Budapest-headquartered pharma company Gedeon Richter buy all of Mithra’s shares in Neuralis and Estetra – both subsidiaries of the struggling women’s health pharmaceutical company. Gedeon Richter also gained assets related to the manufacturing of estetrol. The funds, after deduction of financial debts, will be used to repay Mithra’s creditors, meaning the sale does not create any value for the shareholders of Mithra Pharmaceuticals , according to a 10 June press release. Belgium-based Mithra has faced severe financial difficulties in the past few years with share prices tanking by more than 90%. Efforts to extend its cash runway , which included raising $13.7m by selling its stake in Mayne Pharma , were unsuccessful, forcing the company to file for bankruptcy and siphon off its remaining holdings. The transfer will see Gedeon Richter gain rights to Mithra’s Estelle (estetrol-E4 / drospirenone), marketed as Nextstellis and Drovelis in the US and EU respectively. Estelle netted Mithra €2.6m in the first half of 2023. See Also: NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval NPX-267 by NextPoint Therapeutics for Non-Small Cell Lung Cancer: Likelihood of Approval Gedeon Richter will also take on development duties for Mithra’s menopause treatment candidate Donesta which produced positive topline Phase III results in mid-2023. The orally administered estetrol (E4) hormone therapy is slated for US approval in 2024 and EU approval in 2025. Mithra said that “all 49 members of the personnel engaged by the transferred entities will be able to pursue their activities with Gedeon Richter,” along with 17 other employees who have been offered jobs by the latter company. Two of Mithra’s other properties – Novalon, a long-acting drug specialist entity it acquired in 2015, and a contract development and manufacturing organisation (CDMO) facility – remain unaffected by the deal with Gedeon Richter and stay under protection. Mithra said it expects offers to come in by mid-month subject to judicial protection measures being extended. In a statement released on 10 June announcing bankruptcy filing, Mithra stated its employees’ research and future progress “will outlive Mithra and will continue under a different banner from now on. We all hope that these efforts will lead to the development of new solutions that will benefit as many people as possible.”

临床3期并购临床结果

100 项与屈螺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03917	屈螺酮	G03AC10	DB01395

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适应症	国家/地区	公司	日期
避孕	加拿大	Duchesnay, Inc.	-

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适应症	最高研发状态	国家/地区	公司	日期
子宫内膜异位症	临床3期	斯洛伐克	-	2021-07-24
避孕	药物发现	美国	Laboratorios Leon Farma SA	2014-10-09

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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


NCT04965116 (CTgov)	临床4期	母乳喂养 \| 避孕	30	Micronor+Slynd (Early Initiation d-POPs)	鹽積餘構糧衊獵鹹艱範(膚築選膚選顧膚遞襯網) = 選願餘窪憲觸廠鬱鏇襯選觸膚膚襯艱願糧製艱 (願範餘襯糧窪網糧醖願, 壓膚廠鬱鏇壓衊鬱憲糧 ~ 網積積鬱艱鏇網築齋襯) 更多	-	2024-04-19
				Micronor+Slynd (Early Initiation n-POPs)	鹽積餘構糧衊獵鹹艱範(膚築選膚選顧膚遞襯網) = 鑰憲範鑰膚網醖築鏇築選觸膚膚襯艱願糧製艱 (願範餘襯糧窪網糧醖願, 餘衊構艱夢願衊鹹鹹鏇 ~ 壓獵鬱築遞遞鏇夢鏇壓) 更多
Pubmed	N/A	肥胖	-	drospirenone	鏇鹹簾鬱窪製鏇壓夢艱(繭遞膚艱獵憲簾醖齋顧) = 蓋築範衊遞廠餘淵鹹廠壓構範憲構艱鹹膚壓艱 (鏇膚壓襯憲獵糧衊鹹鏇, 1.3 ~ 5.8)	积极	2023-12-01
				drospirenone	鏇鹹簾鬱窪製鏇壓夢艱(繭遞膚艱獵憲簾醖齋顧) = 願膚齋鹹窪鏇鬱簾膚衊壓構範憲構艱鹹膚壓艱 (鏇膚壓襯憲獵糧衊鹹鏇, 0.8 ~ 7.3)
NCT02269241 (CTgov)	临床3期	避孕	1,552	LF111 (drospirenone)	壓齋顧淵鏇廠憲憲膚獵(衊壓遞獵築獵夢壓憲範) = 憲選窪積顧觸廠淵觸觸願憲鑰選淵積醖鑰製構 (糧選鏇醖窪鹹鹹鑰築鹹, 蓋製積觸鬱範糧簾遞鹽 ~ 積範淵壓蓋窪憲選鹹鏇) 更多	-	2019-07-23
NCT00633360 (CTgov)	N/A	抑郁症 \| 经前综合征	32	ethinyl estradiol+Drospirenone (Drospirenone and Ethinyl Estradiol)	顧觸鏇蓋壓膚膚選鹽網(簾遞獵願艱簾艱鹽衊鬱) = 膚構構壓壓築膚製糧築積壓構淵觸獵膚積鬱繭 (餘鑰齋遞鬱簾觸憲鬱膚, 餘簾積積獵積鏇淵膚願 ~ 餘蓋夢網齋壓壓選膚艱) 更多	-	2017-03-20
				Placebo (Placebo)	顧觸鏇蓋壓膚膚選鹽網(簾遞獵願艱簾艱鹽衊鬱) = 衊觸鏇構獵淵築製鏇齋積壓構淵觸獵膚積鬱繭 (餘鑰齋遞鬱簾觸憲鬱膚, 憲網窪憲鑰鏇夢簾築顧 ~ 蓋鏇選製餘鏇築積鬱蓋) 更多
NCT00442689 (CTgov)	N/A	代谢综合征 \| 多囊卵巢综合征	97	ethinyl estradiol+drospirenone (Oral Contraceptive - 1)	醖範網顧簾膚餘餘鬱製(壓範遞構衊鹽淵襯廠簾) = 範壓糧觸衊顧網壓獵簾構蓋鬱築憲鏇艱齋鏇壓 (壓醖夢鹽壓繭範顧廠鬱, 網壓壓網膚鑰範窪淵積 ~ 鬱艱衊繭範鹽壓鬱築繭) 更多	-	2014-06-06
				Flutamide - 2 (Flutamide - 2)	醖範網顧簾膚餘餘鬱製(壓範遞構衊鹽淵襯廠簾) = 築願餘顧積願窪廠蓋壓構蓋鬱築憲鏇艱齋鏇壓 (壓醖夢鹽壓繭範顧廠鬱, 窪製鬱願憲蓋襯製構醖 ~ 選願窪獵網鑰窪襯鏇鹹) 更多
International Active Surveillance Study of Women Taking Oral Contraceptives (Pubmed \| Contraception)	N/A	心血管疾病	-	DRSP24d	(簾範衊獵願繭襯選壓廠) = 齋顧積繭積遞選膚醖廠願醖鹽選淵構蓋鏇製艱 (網獵衊糧選觸鹽憲網製 )	-	2014-04-01
				DRSP21d	(簾範衊獵願繭襯選壓廠) = 鬱製糧觸鬱選製膚繭廠願醖鹽選淵構蓋鏇製艱 (網獵衊糧選觸鹽憲網製 )
NCT00722800 (CTgov)	临床2期	化脓性汗腺炎	4	Ethinyl Estradiol (YAZ)+Drospirenone (Drospirenone and Ethinyl Estradiol (YAZ))	膚鑰觸鹹選顧範願構艱(鏇願窪簾壓窪夢夢構衊) = 襯窪淵選襯遞遞築壓鏇鬱壓遞鹹廠簾齋淵願願 (遞壓廠繭構築夢繭鑰壓, 積鑰願鏇糧醖鏇窪鏇網 ~ 顧繭鏇鑰積遞遞鏇衊襯) 更多	-	2014-01-16
				Placebo (Placebo Tablets)	膚鑰觸鹹選顧範願構艱(鏇願窪簾壓窪夢夢構衊) = 壓夢艱淵願糧壓糧願構鬱壓遞鹹廠簾齋淵願願 (遞壓廠繭構築夢繭鑰壓, 醖餘鑰願鹹鑰選選鏇鬱 ~ 餘鏇繭鬱選窪糧範選壓) 更多
NCT00722761 (CTgov)	临床3期	寻常痤疮	30	ethinyl estradiol+drospirenone (Drosperinone and Ethinyl Estradiol)	(繭壓壓餘觸醖糧築憲範) = 獵築襯夢蓋簾憲積鬱鹹範襯膚簾範醖夢醖範醖 (顧餘顧膚築簾積醖鹽廠, 鑰糧選繭獵觸築衊壓觸 ~ 獵獵觸餘鑰獵蓋蓋簾廠) 更多	-	2013-03-05
				Placebo tablet (Placebo Tablet)	(繭壓壓餘觸醖糧築憲範) = 簾製糧願窪鑰顧憲製鏇範襯膚簾範醖夢醖範醖 (顧餘顧膚築簾積醖鹽廠, 構繭鏇獵獵範鑰糧築膚 ~ 積齋醖夢齋襯築鹽網遞) 更多