去氧孕烯/炔雌醇(Desogestrel/Ethinyl Estradiol) - 药物靶点：ER x PR_在研适应症：避孕_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Desogestrel/Ethinylestradiol(Organon)、Ethinylestradiol/desogestrel、Mircette

+ [27]

靶点

ER x PR

作用方式

激动剂

作用机制

ERs激动剂(雌激素受体家族激动剂)、PR激动剂(孕激素受体激动剂)

治疗领域

其他疾病

在研适应症

避孕

非在研适应症-

原研机构

Merck Sharp & Dohme Corp.

在研机构

Organon Pharma Pty Ltd.

Fuji Pharma Co., Ltd.Fuji Chemical Industries Ltd.

+ [2]

非在研机构

Organon USA, Inc.

Janssen Pharmaceuticals, Inc.

Bayer AG

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1992-12-10),

避孕

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C42H54O3

InChIKeyMXBCYQUALCBQIJ-RYVPXURESA-N

CAS号71138-35-7

关联

32

项与去氧孕烯/炔雌醇相关的临床试验

NCT06334315

/ Recruiting临床4期IIT

Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users

The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are:
* Do individuals with the CYP3A7*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill?
* Do individuals with the CYP3A7*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill?
* What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users?
Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures:
* Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill
* Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill
* Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill
* A transvaginal ultrasound to measure any ovarian follicles (optional procedure)

开始日期2024-10-29

申办/合作机构

Yale University

[+1]

CTR20221797

/ CompletedN/A

去氧孕烯炔雌醇片在空腹及餐后条件下的人体生物等效性试验

主要研究目的：本研究考察空腹及餐后条件下单次口服由浙江仙琚制药股份有限公司生产的受试制剂去氧孕烯炔雌醇片（规格：每片含去氧孕烯0.15mg和炔雌醇20μg）或由N.V.Organon持证的参比制剂去氧孕烯炔雌醇片（商品名：Mercilon®，规格：每片含去氧孕烯0.15mg和炔雌醇20μg）的药动学特征，评价两制剂的生物等效性，为该受试制剂注册申请提供依据。次要研究目的：观察健康受试者单次口服受试制剂去氧孕烯炔雌醇片（规格：每片含去氧孕烯0.15mg和炔雌醇20μg）或参比制剂去氧孕烯炔雌醇片（商品名：Mercilon®，规格：每片含去氧孕烯0.15mg和炔雌醇20μg）的安全性。

开始日期2023-03-17

申办/合作机构

浙江仙琚制药股份有限公司

NCT05002738

/ Completed临床4期IIT

Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel

This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill.

开始日期2021-09-10

申办/合作机构

University of Colorado Denver

100 项与去氧孕烯/炔雌醇相关的临床结果

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100 项与去氧孕烯/炔雌醇相关的转化医学

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100 项与去氧孕烯/炔雌醇相关的专利（医药）

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525

项与去氧孕烯/炔雌醇相关的文献（医药）

2024-01-01·Journal of Ethnopharmacology

The effect of Ding-kun-dan comparing with Marvelon on primary dysmenorrhea: A prospective, double-blind, multicenter, randomized controlled trial

Article

作者: Ding, Xue-Song ; Zhu, Shi-Yang ; Deng, Yan ; Gan, Jingwen ; Ma, Xiao ; Wang, Yanfang ; Sun, Ai-Jun

ETHNOPHARMACOLOGICAL RELEVANCEDing-kun-dan (DKD), as one of well-known traditional Chinese medicine (TCM), is considered as an effective prescription to regulate menstruation, benefit Qi and nourish the blood. Previous studies had showed that DKD could improve sex hormone levels, insulin resistance, metabolism abnormalities and regulate immunity in animal models with polycystic ovary syndrome or endometriosis, however, little study conducted to reveal its clinical efficacy in Primary Dysmenorrhea (PD).AIM OF THE STUDYTo compare the effect of Ding-kun-dan (DKD) with Marvelon on relief of symptoms and change of serum pain-related factors in patients with primary dysmenorrhea.MATERIALS AND METHOD136 patients with primary dysmenorrhea were randomly assigned to the DKD group (n = 73, take one tablet per day from 5th day of the menstrual cycle for 10 days every 28 days) and the Marvelon group (n = 63, take one tablet per day from 5th day of the menstrual cycle for 21 days every 28 days), the therapeutic effects were analyzed through evaluating the change of VAS scores, CMSS scores and the level of PGF_2a, PGE₂, PGF_2a/PGE₂ and NO during the 12 weeks intervention.RESULTSBoth DKD and Marvelon could effectively relief pain and other associated symptoms at each visit (Baseline, 4^th week, 8^th week and 12^th week). Although Marvelon was significantly superior to DKD in reducing VAS scores, the total CMSS, CMSS severity and duration scores at each posttreatment follow-up (P < 0.01), VAS scores in the DKD group decreased significantly over time while scores in the COC group only dropped rapidly after the first two months of treatment. Efficacy gap between two interventions continuously narrowed over time and the efficacy of DKD became non-inferior at the 12^th week compared to that of Marvelon (the difference between groups, - 0.78%; 95% confidence interval (CI), -13.67%-12.75%; non-inferiority margin, 15%). DKD group had better efficacy on mild pain compared to that of the COC group with no statistical difference (75% VS 61.9%, P > 0.05). DKD and Marvelon could effectively reduce PGF_2a, PGE₂ and higher PGF_2a/PGE₂ in patients with PD. There was no statistical difference in the level of PGF_2a, PGE₂, PGF_2a/PGE₂ and NO between DKD and Marvelon group at each follow-up. No serious adverse effect was observed.CONCLUSIONDing-kun-dan is another available, effective and safe method for patients with primary dysmenorrhea to choose, especially for those who are suffered from mild pain and/or contraindicated to hormonal agents.

2023-07-01·Journal of Cystic Fibrosis

Heterogeneous liver on research ultrasound identifies children with cystic fibrosis at high risk of advanced liver disease

Article

作者: Karmazyn, Boaz ; Nicholas, Jennifer L ; Siegel, Marilyn J ; Alonso, Estella M ; Towbin, Alex J ; Schwarzenberg, Sarah Jane ; Otto, Randolph K ; Narkewicz, Michael R ; Leung, Daniel H ; Karnsakul, Wikrom ; Stoll, Janis ; Navarro, Oscar M ; Paranjape, Shruti M ; Ye, Wen ; Green, Nicole ; Masand, Prakash ; Ling, Simon C ; Palermo, Joseph J ; Freeman, A Jay ; Magee, John C ; Harned, Roger ; Molleston, Jean P ; Alazraki, Adina

BACKGROUNDThis study examines whether heterogeneous (HTG) pattern on liver ultrasound (US) identifies children at risk for advanced cystic fibrosis liver disease (aCFLD).METHODSProspective 6-year multicenter case-controlled cohort study. Children with pancreatic insufficient cystic fibrosis (CF) aged 3-12 years without known cirrhosis underwent screening US. Participants with HTG were matched (by age, Pseudomonas infection status and center) 1:2 with participants with normal (NL) US pattern. Clinical status and laboratory data were obtained annually and US bi-annually for 6 years. Primary endpoint was development of nodular (NOD) US pattern consistent with aCFLD.RESULTS722 participants underwent screening US, with 65 HTG and 592 NL. Final cohort included 55 HTG and 116 NL with ≥ 1 follow-up US. ALT, AST, GGTP, FIB-4, GPR and APRI were higher, and platelets were lower in HTG compared to NL. HTG had a 9.5-fold increased incidence (95% confidence interval [CI]:3.4, 26.7, p<0.0001, 32.7% vs 3.4%) of NOD versus NL. HTG had a sensitivity of 82% and specificity of 75% for subsequent NOD. Negative predictive value of a NL US for subsequent NOD was 96%. Multivariate logistic prediction model that included baseline US, age, and log(GPR) improved the C-index to 0.90 compared to only baseline US (C-index 0.78). Based on survival analysis, 50% of HTG develop NOD after 8 years.CONCLUSIONSResearch US finding of HTG identifies children with CF with a 30-50% risk for aCFLD. A score based on US pattern, age and GPR may refine the identification of individuals at high risk for aCFLD.CLINICAL TRIAL REGISTRATIONProspective Study of Ultrasound to Predict Hepatic Cirrhosis in CF: NCT 01,144,507 (observational study, no consort checklist).

2022-06-01·Lasers in Medical Science3区 · 工程技术

Comparative evaluation of low-level light therapy and ethinyl estradiol and desogestrel combined oral contraceptive for clinical efficacy and regulation of serum biochemical parameters in primary dysmenorrhoea: a prospective randomised multicentre trial

3区 · 工程技术

Article

作者: Deng, Yan ; Zhu, Shiyang ; Ding, Xuesong ; Ma, Xiao ; Gan, Jingwen ; Wang, Yanfang ; Sun, Aijun

We aimed to compare low-level light therapy with oral contraceptive pills for pain relief and serum levels of nitric oxide and prostaglandin E₂ in patients with primary dysmenorrhoea. This was a randomised, active comparator-controlled, multicentre study. In total, 156 patients were randomised to receive either low-level light therapy with light-emitting diodes (LED) applying on two acupoints, namely, conception vessel 4 (CV4) and CV6 or conventional treatment with oral Marvelon, 30 µg of ethinyl estradiol and 150 µg of desogestrel (DSG/EE), for three consecutive menstrual cycles. The main outcome was the proportion of patients who achieved 33% or more decrease in pain scores measured using the visual analogue scale, which was deemed as efficient rate. Absolute changes in visual analogue scale scores, serum levels of nitric oxide (assessed by nitrites and nitrates reflecting nitric oxide metabolism) and prostaglandin E₂ (measured by enzyme-linked immunosorbent assay) were the secondary outcomes. A total of 135 patients completed the study (73 in the light therapy group and 62 in the DSG/EE group). The efficient rate at the end of treatment was comparable between the groups (73.6% vs. 85.7%, χ² = 2.994, p = 0.084). A more significant reduction in pain scores was observed in the DSG/EE group (39.25% vs. 59.52%, p < 0.001). Serum levels of prostaglandin E₂ significantly decreased from baseline but did not differ between groups (- 109.57 ± 3.99 pg/mL vs. - 118.11 ± 12.93 pg/mL, p = 0.51). Nitric oxide concentration remained stable in both groups. Low-level light therapy with LED-based device applied on acupuncture points CV4 and CV6 demonstrated a similar level of dysmenorrhoea pain reduction to DSG/EE combined contraceptive. Both treatment modalities achieved clinically meaningful levels of pain reduction. Registration on ClinicalTrials.gov: TRN: NCT03953716, Date: April 04, 2019.

17

项与去氧孕烯/炔雌醇相关的新闻（医药）

2025-03-10

·药筛

洛索洛芬钠凝胶贴膏第5家过评，喷他佐辛第4家，去氧孕烯炔雌醇第3家，沙美特罗替卡松粉雾剂第2家

周一，NMPA批文大放送，有多个新药，也有很多不错的仿制药。重点说说和代理商相关的仿制药。湖南九典的洛索洛芬钠凝胶贴膏获批上市，第5家过评价，离集采资格越来越近了。山东新华的喷他佐辛注射液获批上市，第4家批文，分蛋糕的人越来越多。浙江仙琚的去氧孕烯炔雌醇片，第3个国产仿制。四川普锐特的沙美特罗替卡松吸入粉雾剂获批上市，继健康元之后的第2家仿制，高难度，有壁垒，后面申报的企业不算多。四川汇宇的注射用塞替派获批上市，继恒瑞后的第2家。塞替派是一种烷化剂，适应症是用于重型β-地中海贫血儿童异基因造血干细胞移植前预处理。目前是当前适应症中，唯一的药物。国内市场，有注射液剂型在售，恒瑞的粉针剂是去年获批，15mg单价3290元。

上市批准一致性评价

2024-10-21

·E药经理人

欣妈富隆上线电商渠道阿里健康大药房首发

10月20日，欧加隆旗下复方口服避孕药欣妈富隆（通用名：去氧孕烯炔雌醇片）正式在阿里健康大药房线上首发。作为国内目前唯一获批避孕和月经周期调控双适应症的复方短效口服避孕药，欣妈富隆上线互联网医药平台后，将全面提升用药可及性，助力女性获得包括避孕、月经健康、生育力保护在内的健康呵护。复方口服避孕药（combined oral contraceptives，COC）是目前全球范围广泛使用的高效避孕方法之一，是含有低剂量雌激素和孕激素（与女性体内天然的雌激素和孕激素相似）的复合甾体激素制剂。正确使用 COC 不仅可以有效避孕，还可以调节月经。数据显示，目前超过1/3的育龄期女性受到月经紊乱的困扰。一项纳入15个省市100个社区9951名女性的妇科常见病的随机抽样调查，结果显示，未绝经的女性中，月经紊乱女性占34.5%。北京协和医院妇产科田秦杰教授指出，规律月经是女性生殖健康非常重要的信号，与生殖内分泌系统息息相关。月经周期规律性为相邻两次月经周期天数相差不超过7天，经期长度为7天以内，经期出血量为5-80mL可以称之为月经正常。现代社会女性的观念依然传统，并不认为月经失调是一种疾病，由于大多数女性对月经的认知不准确，即使发生了异常月经，也意识不到其潜在的问题，不会选择到医院寻求医生的帮助。 “尤其对于刚初潮后的青春期女性，尚不能形成比较规律的月经周期。其实，临床有很多种方式可以管理月经异常，比如在医生的指导下，服用短效口服避孕药调节月经周期也是一种方式，来提高学习、生活和工作质量。”田秦杰说。资料显示，欣妈富隆（去氧孕烯炔雌醇片）是全球首个获批20μg炔雌醇的复方口服短效避孕药COC，在全球有超过40年的使用经验，也是继妈富隆（去氧孕烯炔雌醇片）后又一款低剂量炔雌醇(EE)产品，为女性提供更丰富的生殖健康守护和赋权自我的力量。 2022年，欣妈富隆正式回归中国市场，并于2023年7月正式进入国内医院。双通道政策下，今年5月，欣妈富隆正式进驻零售药店，10月正式在医药电商平台开售，实现了院内院外的全渠道便捷可及。据了解，此次欧加隆联合阿里健康线上首发欣妈富隆，将借助阿里健康遍及全国百城的专业药品仓配体系与互联网诊疗能力，为更多中国女性提供专业有效、正品优质的创新治疗方案与药品服务。关爱女性多样化的健康需求，为女性管理自身特有健康需求提供便利。一审| 黄佳二审| 李芳晨三审| 李静芝

2024-10-20

·E药经理人

欧加隆携手阿里健康欣妈富隆上线电商

10月20日，欧加隆旗下复方口服避孕药欣妈富隆（通用名：去氧孕烯炔雌醇片）正式在阿里健康大药房线上首发。作为国内目前唯一获批避孕和月经周期调控双适应症的复方短效口服避孕药，欣妈富隆上线互联网医药平台后，将全面提升用药可及性，助力女性获得包括避孕、月经健康、生育力保护在内的健康呵护。复方口服避孕药（combined oral contraceptives，COC）是目前全球范围广泛使用的高效避孕方法之一，是含有低剂量雌激素和孕激素（与女性体内天然的雌激素和孕激素相似）的复合甾体激素制剂。正确使用 COC 不仅可以有效避孕，还可以调节月经。数据显示，目前超过1/3的育龄期女性受到月经紊乱的困扰。一项纳入15个省市100个社区9951名女性的妇科常见病的随机抽样调查，结果显示，未绝经的女性中，月经紊乱女性占34.5%。北京协和医院妇产科田秦杰教授指出，规律月经是女性生殖健康非常重要的信号，与生殖内分泌系统息息相关。月经周期规律性为相邻两次月经周期天数相差不超过7天，经期长度为7天以内，经期出血量为5-80mL可以称之为月经正常。现代社会女性的观念依然传统，并不认为月经失调是一种疾病，由于大多数女性对月经的认知不准确，即使发生了异常月经，也意识不到其潜在的问题，不会选择到医院寻求医生的帮助。 “尤其对于刚初潮后的青春期女性，尚不能形成比较规律的月经周期。其实，临床有很多种方式可以管理月经异常，比如在医生的指导下，服用短效口服避孕药调节月经周期也是一种方式，来提高学习、生活和工作质量。”田秦杰说。资料显示，欣妈富隆（去氧孕烯炔雌醇片）是全球首个获批20μg炔雌醇的复方口服短效避孕药COC，在全球有超过40年的使用经验，也是继妈富隆（去氧孕烯炔雌醇片）后又一款低剂量炔雌醇(EE)产品，为女性提供更丰富的生殖健康守护和赋权自我的力量。 2022年，欣妈富隆正式回归中国市场，并于2023年7月正式进入国内医院。双通道政策下，今年5月，欣妈富隆正式进驻零售药店，10月正式在医药电商平台开售，实现了院内院外的全渠道便捷可及。据了解，此次欧加隆联合阿里健康线上首发欣妈富隆，将借助阿里健康遍及全国百城的专业药品仓配体系与互联网诊疗能力，为更多中国女性提供专业有效、正品优质的创新治疗方案与药品服务。关爱女性多样化的健康需求，为女性管理自身特有健康需求提供便利。一审| 黄佳二审| 李芳晨三审| 李静芝

临床研究

100 项与去氧孕烯/炔雌醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03AB05 G03AA09	-

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
避孕	中国	Organon & Co.	-

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
避孕	药物发现	美国	Organon USA, Inc.	1992-12-10

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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


NCT00544882 (CTgov)	临床3期	-	61	DR-1021 (DR-1021)	醖製積觸積繭憲築鏇廠(衊鏇齋網範餘願鬱餘製) = 繭襯遞遞廠鬱觸構遞蓋遞壓餘鹹蓋獵壓鹹醖艱 (鹽遞窪鏇製構積鑰艱遞, 夢顧醖齋醖艱顧淵鑰鏇 ~ 醖襯醖糧夢夢積夢觸鹹) 更多	-	2014-06-10
				Mircette® (Mircette)	醖製積觸積繭憲築鏇廠(衊鏇齋網範餘願鬱餘製) = 艱積製築構鹹餘遞艱壓遞壓餘鹹蓋獵壓鹹醖艱 (鹽遞窪鏇製構積鑰艱遞, 糧糧鹽範鬱範範遞範鏇 ~ 夢衊簾觸鑰鏇艱醖積製) 更多
NCT01388491 (CTgov)	临床2期	避孕	293	desogestrel/ethinyl estradiol+ethinyl estradiol (Treatment I: (DR-102))	範廠艱膚廠艱膚鏇獵艱(襯鹹願衊網鏇積願願觸) = 窪壓鹹糧積觸願積襯憲膚獵淵糧艱獵窪衊壓鏇 (鏇餘窪艱鹽鑰襯積襯壓, 繭窪顧齋淵壓鑰網鬱顧 ~ 築襯糧淵鬱夢構淵淵構) 更多	-	2013-11-27
				desogestrel/ethinyl estradiol (Treatment II)	範廠艱膚廠艱膚鏇獵艱(襯鹹願衊網鏇積願願觸) = 鬱窪築艱鹹蓋窪窪遞鹽膚獵淵糧艱獵窪衊壓鏇 (鏇餘窪艱鹽鑰襯積襯壓, 積蓋壓積觸蓋願夢簾鏇 ~ 積繭網淵顧齋憲遞獵繭) 更多
NCT00612508 (CTgov)	N/A	阴道疾病 \| 避孕行为	14	Desogen (ethinyl estradiol+desogestrel) (Desogen)	蓋襯網獵醖襯築構壓選(憲襯廠鑰憲願構鹹選廠) = 顧鏇鹹選簾獵繭觸糧顧築艱簾衊選觸醖鹽遞齋 (壓簾餘醖艱積醖鏇餘蓋, 蓋鑰艱簾窪構淵齋鏇願 ~ 醖齋淵鬱選繭糧遞鑰廠) 更多	-	2012-11-08
				NuvaRing (ethinyl estradiol+etonogestrel) (NuvaRing)	蓋襯網獵醖襯築構壓選(憲襯廠鑰憲願構鹹選廠) = 夢選憲顧窪糧鏇鬱醖簾築艱簾衊選觸醖鹽遞齋 (壓簾餘醖艱積醖鏇餘蓋, 願艱製艱醖繭選廠壓製 ~ 壓選淵顧鏇艱獵襯醖遞) 更多