炔雌醇/诺孕酯(Ethinyl Estradiol/Norgestimate) - 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

Ethinylestradiol/norgestimate oral、NORGESTIMATE/ETHINYL ESTRADIOL、Ortho Tri-Cyclen

+ [18]

靶点

ER x PR

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

在研适应症

非在研适应症

原研机构

在研机构

Ortho-McNeil Pharmaceutical LLC

非在研机构

McNeil Consumer & Specialty Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development LLC

Janssen Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

美国 (1989-12-29),

避孕

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C43H55NO5

InChIKeyGYMWQLRSSDFGEQ-CXNPBKRFSA-N

CAS号79871-54-8

关联

30

项与炔雌醇/诺孕酯相关的临床试验

EUCTR2021-003027-15-IT

/ Unknown status临床4期

A multicentre, prospective, open-label, non-comparative study to evaluate menstrual bleeding typology, tolerability, and compliance during a monophasic hormonal contraceptive treatment with norgestimate + ethinylestradiol in Italy. - NA

开始日期2023-03-20

申办/合作机构

Italfarmaco SpA

NCT04828824

/ Recruiting临床4期IIT

Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

开始日期2021-06-18

申办/合作机构

University of Colorado Denver

NCT04172987

/ Completed临床1期

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.

开始日期2020-02-26

申办/合作机构

Eli Lilly & Co.

100 项与炔雌醇/诺孕酯相关的临床结果

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100 项与炔雌醇/诺孕酯相关的转化医学

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100 项与炔雌醇/诺孕酯相关的专利（医药）

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136

项与炔雌醇/诺孕酯相关的文献（医药）

2024-12-18·Environmental technology

A dual-mode ratiometric probe using europium-doped cyclen-functional carbon dots for fluorescent and point-of-care detection of tetracycline

Article

作者: Hsieh, ShihHuan ; Zhang, Weiluo ; Li, Huiling ; Chen, Yuan ; Zheng, Lei ; Li, Mingzhu ; Li, Yuanhua ; Yang, Xiaofang ; Feng, Kejun ; Yan, Binghua

The overuse of tetracycline (TC) has led to the accumulation of antibiotic residues in drinking water and animal products, which can consequently lead to bacteria resistance and chronic disease in humans. Urgently addressing the need for a rapid, user-friendly, and point-of-care test for TC detection. In this work, we use cyclen and citric acid to synthesise carbon dots (CDs) with a unique ring-shaped structure on their surface and combine them with europium (Eu³⁺) to form an Eu-CDs fluorescent probe. In the presence of TC in aqueous systems, the Eu-CDs probe emits two distinctive fluorescent signals: the stable blue emission from cyclen-modified CDs and the red emission from Eu³⁺,showing a proportional increase with TC concentration. The developed Eu-CDs probe demonstrates accurate and selective detection capabilities for TC class antibiotics among various interfering factors. The Eu-CDs probe exhibits excellent linearity within the concentration range of 0.04-2.4 µM and achieves an impressive detection limit of 2.7 nM. Moreover, point-of-care Eu-CDs test strips are designed, allowing convenient on-site TC analysis through the detection of a colour change from blue to red under a portable UV light. The results highlight the effectiveness of the proposed dual-mode ratiometric fluorescent Eu-CDs probe and test strips, offering a practical point-of-care testing strategy for real-world TC detection applications.

2022-08-01·PHARMACEUTICAL CHEMISTRY JOURNAL

Validation of the Specificity of Chromatographic Methods: Key Points and Practical Recommendations

作者: Epshtein, N. A.

Specificity is one of the main tasks in reliable validation of anal. methods.Experience has shown that this problem is often treated rather formally in the case of using chromatog. methods for the determination of organic impurities so that the specificity of a proposed method is not fully proven.This article discusses key points for reliable assessment of the specificity of methods used for determining impurities.Practical recommendations and numerical values for decision making are given.The specificity of a method must be tested by conducting stress testing in such a way that the given API under stress degrades, i.e., the content of drug in the primary substance decreases, by greater than 0.5%.This is necessary at a min. for noticing the growth of existing impurities in the API and the formation of new impurities.On the other hand, the API degradation should not exceed 2% under oxidative stress and photodegradation conditions and should not exceed 5% for other stress factors (so as to minimize secondary reactions).The condition of permissible overlap of impurity peaks in the validation of method specificity has been substantiated as follows: the peak-to-valley (p/v) ratio should be ≥1.5 for overlapping impurity peaks.This is usually sufficient for ensuring reproducibility of the overlapping peak areas.If the overlapping peaks are close in height, then the p/v ratio can be <1.5 provided that the relative standard deviation of the area of overlapping peaks does not exceed 6% for successive injections (RSD ∼ 6%).This condition corresponds to a baseline signal-to-noise ratio S/N = 10, i.e., the limit of quantification.Issues related to validation of the specificity of methods for determining impurities in combined drugs are considered.

2021-09-20·Inorganic chemistry2区 · 化学

Antiparallel Coupling between a 4f System and a Photoexcited Cyclic π System in a Dysprosium(III) Monoporphyrinato Complex

2区 · 化学

Article

作者: Ishikawa, Naoto ; Santria, Anas

Magnetic coupling resulted by an orbital angular momentum L of a photoexcited cyclic π-conjugated system and total angular momentum J of a localized 4f electronic system in [Dy(TPP)(cyclen)]Cl (TPP = 5,10,15,20-tetraphenylporphyrinato; cyclen = 1,4,7,10-tetraazacyclododecane) has been identified using magnetic circular dichroism (MCD). The MCD A-term patterns of the compound show a negative increment in the intensity by decreasing temperature and nonproportionality to the magnetic field. This phenomenon is experimentally observed for the first time in porphyrin-based lanthanide complexes and indicates the presence of the J-L interaction, with the preferred orientation being antiparallel. A theoretical model in which J and L are assumed to couple antiferromagnetically yielded a quantitative agreement to the experimental data of varied-temperature and varied-magnetic-field MCD spectral measurements. The ab initio calculations were performed, revealing the relationship between two orbital angular momenta, i.e., L(π) and L(f), which result from the delocalized π system and the localized 4f system, respectively.

1

项与炔雌醇/诺孕酯相关的新闻（医药）

2021-03-04

·BioSpace

Mayne Pharma launches another generic oral contraceptive

ADELAIDE, Australia, March 4, 2021 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the commercial launch of a generic version of ORTHO-CEPT® (desogestrel and ethinyl estradiol 0.15 mg / 0.03 mg) tablets to customers in the US. This is the fourth oral contraceptive launched this calendar year after launching generic versions of LOESTRIN® 24 FE, ORTHO CYCLEN® and ORTHO TRI-CYCLEN®. According to IQVIA, the annual US market sales for the four products were approximately US$315 million in the twelve months ending January 2021[1]. Mayne Pharma's CEO Scott Richards said, "We are very pleased to expand our Women's Health portfolio which now covers ~80% of Obstetrician/Gynaecologist oral contraceptive prescription volumes[1] and includes 24 marketed branded generic contraceptives. Mayne Pharma is committed to helping meet the needs of women in the US by providing cost effective, high-quality and novel contraceptive options. The four new products launched this year were sourced from the strategic partnership with Novast Laboratories." "In addition, Mayne Pharma has four women's health pipeline products pending at the FDA including the novel combined oral contraceptive NEXTSTELLIS™ (E4/DRSP) and a generic version of NUVARING®. NEXTSTELLIS which has a FDA target action date in April contains a new estrogen called estetrol or E4 in combination with a progestin, drospirenone. If approved, E4 will be the first new estrogen introduced in the US for contraceptive use in approximately 50 years." About Mayne Pharma Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, offering patients better and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide. Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that continue to be marketed around the world. Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds. LOESTRIN® 24 FE, NEXTSTELLIS™, NUVARING®, ORTHO-CEPT®, ORTHO CYCLEN® and ORTHO TRI-CYCLEN® are registered trademarks of third parties. [1] IQVIA, MAT Sales and NSP Units for brand and generic equivalents, January 2021 Company Codes: Australia:MYX, OTC-PINK:MYPHY

合作

100 项与炔雌醇/诺孕酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G03AA11 G03AB09	-

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	美国	Janssen Pharmaceuticals, Inc.	1989-12-29

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
出血	临床2期	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	2003-11-01
子宫不规则出血	临床2期	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	2003-11-01

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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


AAN2019	临床1期	-	22	Ubrogepant 50 mg	淵製蓋製獵顧憲壓範鑰(蓋鹽繭餘範衊膚淵繭築) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 獵願膚簾選築鬱衊鏇製 (鑰鏇鏇製願遞艱窪窪憲 ) 更多	积极	2019-04-09
				Ortho-Cyclen (ethinyl estradiol/norgestimate)
NCT01475513 (CTgov)	临床4期	胰岛素抵抗	47	Ortho Cyclen® (African-American Women)	繭積製糧觸廠顧鑰網鏇(艱構糧憲觸網範鹹淵鑰) = 夢廠網衊獵選築齋艱膚顧餘製簾繭齋醖獵築範 (壓壓廠獵膚遞醖獵網繭, 蓋衊觸遞衊鹹蓋糧遞鬱 ~ 廠繭鹹壓醖憲簾願構獵) 更多	-	2018-07-10
				Ortho Cyclen® (Caucasian Women)	繭積製糧觸廠顧鑰網鏇(艱構糧憲觸網範鹹淵鑰) = 糧窪選鏇簾憲製廠糧簾顧餘製簾繭齋醖獵築範 (壓壓廠獵膚遞醖獵網繭, 願築鏇鏇鏇顧鏇齋壓築 ~ 壓網願壓鏇積選艱窪齋) 更多
NCT00775190 (CTgov)	N/A	避孕	12	ortho tricyclen (Ortho Tricyclen™)	衊鬱齋醖範製膚製鹽憲(鹹願夢願齋簾願窪蓋獵) = 醖鬱餘製廠鹽繭艱鏇顧衊餘膚觸願艱憲餘壓衊 (壓膚構鹹範憲廠衊憲簾, 壓糧鹽鬱製膚窪獵襯願 ~ 範衊簾遞願蓋繭艱鑰艱) 更多	-	2017-04-17
				Trinessa (Trinessa™)	衊鬱齋醖範製膚製鹽憲(鹹願夢願齋簾願窪蓋獵) = 鹽醖襯鹹淵獵願獵築齋衊餘膚觸願艱憲餘壓衊 (壓膚構鹹範憲廠衊憲簾, 壓淵製壓遞構製窪構憲 ~ 艱簾壓壓衊醖壓願醖鬱) 更多
NCT01466673 (CTgov)	临床4期	寻常痤疮	201	Ethinyl estradiol/Norgestimate (EE/NGM) (Ethinyl Estradiol/Norgestimate (EE/NGM))	網鏇廠願鬱簾鏇繭觸衊(壓餘鬱選構網鑰膚憲鏇) = 簾窪鏇構艱憲襯蓋遞願構鑰選憲築選糧衊鏇網 (窪鬱鬱廠廠簾遞鹽夢窪, 憲築餘願餘顧齋齋夢簾 ~ 窪簾構築遞構鹽窪衊獵) 更多	-	2013-06-19
				Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG))	網鏇廠願鬱簾鏇繭觸衊(壓餘鬱選構網鑰膚憲鏇) = 鑰網範糧衊獵艱觸願願構鑰選憲築選糧衊鏇網 (窪鬱鬱廠廠簾遞鹽夢窪, 鹹鑰選遞觸衊艱選鹹鬱 ~ 蓋糧餘蓋製網夢繭願構) 更多
NCT00635570 (ACCEPT, CTgov)	临床4期	避孕	273	NuvaRing (Contraceptive Vaginal Ring)	餘獵艱積鑰鹹鬱窪遞選(繭憲壓繭築顧餘齋鏇鑰) = 繭鬱壓醖網遞繭蓋廠範觸夢顧遞襯遞艱築艱淵 (觸糧顧製憲製淵窪淵繭, 鏇遞獵蓋簾築製襯衊醖 ~ 鏇餘廠鹹餘齋憲構鹽糧) 更多	-	2012-11-07
				Ortho Tri-cyclen Lo (Oral Contraceptive Pill)	餘獵艱積鑰鹹鬱窪遞選(繭憲壓繭築顧餘齋鏇鑰) = 鑰廠淵製願鑰蓋製壓願觸夢顧遞襯遞艱築艱淵 (觸糧顧製憲製淵窪淵繭, 鏇繭觸壓夢獵遞鏇範選 ~ 鬱醖餘齋壓壓鏇齋襯願) 更多
NCT00205504 (Pubmed \| Fertil Steril)	临床4期	-	46	combined hormonal oral contraceptive (Lean women)	夢獵簾積觸獵觸夢淵遞(衊窪遞衊鬱選選築衊觸) = 蓋築築繭製蓋糧範糧糧獵廠顧餘鬱製窪選遞鑰 (鑰構齋顧遞鬱簾鹽願觸 )	-	2011-08-01
				combined hormonal oral contraceptive (Obese women)	夢獵簾積觸獵觸夢淵遞(衊窪遞衊鬱選選築衊觸) = 遞壓顧糧鹹鬱製鏇網壓獵廠顧餘鬱製窪選遞鑰 (鑰構齋顧遞鬱簾鹽願觸 )