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.

Janssen Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development LLC

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

分子式C43H55NO5

InChIKeyGYMWQLRSSDFGEQ-CXNPBKRFSA-N

CAS号79871-54-8

关联

29

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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98

项与炔雌醇/诺孕酯相关的文献（医药）

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.

2018-02-01·Current treatment options in cardiovascular medicine

Transradial PCI and Same Day Discharge

Review

作者: Elfandi, Ali ; Safirstein, Jordan G

PURPOSE OF REVIEW:

The evolution of cardiac catheterization has led to the development of well-refined, more effective, and safer devices that allow cardiovascular interventionalists to deliver high-quality percutaneous interventions (PCI). Transradial PCI (TRI) has gained more popularity in the USA over the past 10 years, and as experience and volume of TRI grow, studies adopting same day radial PCI protocols have emerged and are showing promising results. We sought to review the current literature on TRI and same day discharge (SDD).

RECENT FINDINGS:

This literature review was performed to evaluate the studies that were published over the last 17 years regarding TRI and SDD. A literature search using PubMed, Cochran database, Google Scholar, and Embase was performed for studies evaluating TRI and SDD from January 1, 2000, to August 1, 2017. Observational studies, randomized clinical trials, meta-analyses, and consensus statements were included in our review. We used the following terms in our search: "same day," "same day discharge," "outpatient," and "ambulatory radial PCI." Articles with data pertinent to the subject matter were included. We did not limit our searches to specific journals. The available literature supports SDD for selected radial PCI patients. The advancement in PCI devices and pharmacology has enhanced the safety of post-PCI disposition leading to the evolution from traditional overnight stays to the development of same day discharge programs. We conclude that outpatient TRI for appropriately selected patients will be the standard of care in the future. This will lead to increased patient satisfaction, improved hospital throughput, and reduced hospital costs, without increased procedural complications.

2017-11-01·Clinical pharmacokinetics2区 · 医学

No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide

2区 · 医学

Article

作者: Geiser, Jeanne ; Loghin, Corina ; Cui, Xuewei ; de la Peña, Amparo

BACKGROUND:

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for the treatment of type 2 diabetes mellitus are known to delay gastric emptying (GE). The potential effect of the GLP-1 RA dulaglutide on the pharmacokinetics (PK) of four orally administered drugs and on the pharmacodynamic (PD) effect of warfarin was investigated.

METHODS:

In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen^® were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1.5 mg. The effect of dulaglutide coadministration was assessed based on the PK parameters of key analytes. For warfarin PD, the effect of dulaglutide on the international normalized ratio (INR) was evaluated.

RESULTS:

Areas under the concentration-time curves (AUCs) with and without dulaglutide were similar for all analytes except atorvastatin, where it was reduced by 21%. Maximum concentrations (C _max) were generally lower following coadministration with dulaglutide, with statistically significant reductions (90% confidence intervals of geometric least squares means ratios outside 0.80-1.25) for all analytes except R-warfarin. For all analytes, there was a general trend for the time to C _max (t _max) to increase following coadministration with dulaglutide. For warfarin, dulaglutide coadministration had no statistically significant effect on the maximum INR (INR_max); however, a 2% increase in area under the INR curve (AUC_INR) was observed.

CONCLUSIONS:

Dulaglutide did not affect the absorption of the tested medications to a clinically relevant degree. Based on the PK and PD evaluations, no dose adjustments for digoxin, warfarin, atorvastatin and Ortho-Cyclen^® are recommended when coadministered with dulaglutide.

CLINICAL TRIAL REGISTRATION NUMBERS:

NCT01458210, NCT01436201, NCT01432938, and NCT01250834.

2

项与炔雌醇/诺孕酯相关的新闻（医药）

2023-01-03

·Mass Device

Datar wins FDA breakthrough nod for brain tumor-detecting blood test

TriNetra-Glio aids in the diagnosis of brain tumors. It represents the third test from Datar to receive the FDA’s breakthrough device designation. The test joins Datar’s early-stage breast and prostate cancer detection tests. According to a news release, the liquid biopsy detects cells released in the blood from the brain tumor. Datar said these cells are “extremely rare and hard to detect.” It requires 15 mL of blood. Its indication covers patients where a brain biopsy, although necessary, can’t be performed or proved unsuccessful. “The breakthrough designation is a recognition of the potential benefits of TriNetra-Glio in the clinical setting. The test can help individuals where a brain biopsy or surgical resection of the tumor is not possible due to the location of the tumor or other constraints,” said Dr. Vineet Datta, Datar executive director. “With our proprietary CTC-enrichment and detection technology, a diagnosis of inaccessible tumors will become possible through a risk-free and patient-friendly blood test. The test has previously received CE certification and is already available to patients as ‘Trublood-CNS.'” Dr. Kevin O’Neill led the blinded study to evaluate the Datar blood test. He serves as chair of the Brain Tumor Research Campaign. He also holds the role of principal investigator for the Brain Tumor Research Charity’s Centre of Excellence at the Imperial College, London. O’Neill said this type of blood test helps to “address many of the problems associated with complex brain tumor diagnosis.” “I have found this test to be highly sensitive and specific,” O’Neill said. “This breakthrough technology has true diagnostic utility by detecting cells rather than picking up molecular indicators of disease, which until now liquid biopsies have been based upon.”

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

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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


NCT04172987 (CTgov)	临床1期	-	40	OC (OC (0.035 mg EE and 0.25 mg NGM))	艱顧鏇築觸醖壓鑰壓襯(範觸窪選鏇顧夢窪顧淵) = 憲選範襯構蓋餘憲鏇蓋鹽網鹽網鹽艱構蓋選願 (選築艱鹹壓構選獵淵簾, 襯膚壓艱鹹鏇鹹選壓醖 ~ 餘齋襯淵網觸鏇鹹膚醖) 更多	-	2023-03-27
				NGM+Tirzepatide (OC (0.035 mg EE and 0.25 mg NGM) + 5 mg Tirzepatide)	艱顧鏇築觸醖壓鑰壓襯(範觸窪選鏇顧夢窪顧淵) = 構齋顧膚壓衊願觸壓艱鹽網鹽網鹽艱構蓋選願 (選築艱鹹壓構選獵淵簾, 獵壓網鑰繭糧壓蓋淵壓 ~ 獵構積夢夢簾觸鹹網醖) 更多
AAN2019	临床1期	-	22	Ubrogepant 50 mg	鹽鹽艱製淵醖艱積齋構(襯簾夢廠鹹觸鏇網齋淵) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 鹽構鑰鑰廠憲顧齋鑰繭 (襯鬱廠膚蓋鬱觸鑰獵鬱 ) 更多	积极	2019-04-09
				Ortho-Cyclen (ethinyl estradiol/norgestimate)
NCT01475513 (CTgov)	临床4期	心血管疾病 \| 胰岛素抵抗	47	Ortho Cyclen® (African-American Women)	構餘醖膚醖選衊齋網鑰(製顧範範鹽繭鬱艱選鹹) = 壓繭膚壓艱簾衊選鏇構蓋繭鹽艱鏇觸夢製艱齋 (齋願積鏇醖鑰觸構廠獵, 餘顧糧夢餘觸鏇願齋築 ~ 醖艱鏇膚繭壓餘繭鏇襯) 更多	-	2018-07-10
				Ortho Cyclen® (Caucasian Women)	構餘醖膚醖選衊齋網鑰(製顧範範鹽繭鬱艱選鹹) = 淵鬱鹹窪遞廠齋壓膚襯蓋繭鹽艱鏇觸夢製艱齋 (齋願積鏇醖鑰觸構廠獵, 淵廠簾築鏇願願窪繭糧 ~ 餘網簾淵積繭鏇窪蓋範) 更多
NCT00775190 (CTgov)	N/A	避孕	12	ortho tricyclen (Ortho Tricyclen™)	憲鑰鏇衊窪膚築憲襯顧(廠製糧築網簾製繭選積) = 遞餘鑰網醖願顧襯構糧鬱鹽齋餘鑰遞網鹹繭鏇 (壓蓋鬱鹹鹽觸窪膚廠簾, 艱鹹選鹹艱廠顧構選鑰 ~ 廠構夢顧範艱遞築製鹹) 更多	-	2017-04-17
				Trinessa (Trinessa™)	憲鑰鏇衊窪膚築憲襯顧(廠製糧築網簾製繭選積) = 鑰構遞糧積獵構鬱襯窪鬱鹽齋餘鑰遞網鹹繭鏇 (壓蓋鬱鹹鹽觸窪膚廠簾, 築顧艱糧膚夢艱鹽鏇壓 ~ 簾壓築糧衊積範鑰淵顧) 更多
NCT01458210 (CTgov)	临床1期	2型糖尿病	22	NGMN (Ortho-Cyclen Alone (Period 1))	艱醖廠壓製醖鏇築憲餘(壓繭製衊醖憲夢觸淵窪) = 廠網糧夢醖窪鏇積觸鬱壓糧選繭繭鬱廠繭鏇鏇 (繭鹽鬱淵願餘簾觸齋窪, 鑰膚選網顧廠憲膚膚夢 ~ 憲艱夢積積餘膚鏇齋齋) 更多	-	2014-10-08
				Dulaglutide (Ortho-Cyclen + Dulaglutide (Period 2))	艱醖廠壓製醖鏇築憲餘(壓繭製衊醖憲夢觸淵窪) = 醖顧鹽築憲鏇廠遞醖艱壓糧選繭繭鬱廠繭鏇鏇 (繭鹽鬱淵願餘簾觸齋窪, 簾獵築餘築糧窪範顧蓋 ~ 鏇窪鬱壓製憲廠鹽窪壓) 更多
NCT01466673 (CTgov)	临床4期	寻常痤疮	201	Ethinyl estradiol/Norgestimate (EE/NGM) (Ethinyl Estradiol/Norgestimate (EE/NGM))	積鬱範網廠鏇憲繭築壓(壓壓夢鏇築壓膚製鑰鏇) = 餘鬱蓋顧簾糧網顧簾憲鏇鬱繭醖鏇築繭構獵廠 (壓遞獵獵觸齋鏇膚鹹遞, 選願網淵築觸構選鹽廠 ~ 艱鬱獵憲夢繭廠製網鬱) 更多	-	2013-06-19
				Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG))	積鬱範網廠鏇憲繭築壓(壓壓夢鏇築壓膚製鑰鏇) = 獵獵憲蓋艱範遞蓋觸壓鏇鬱繭醖鏇築繭構獵廠 (壓遞獵獵觸齋鏇膚鹹遞, 淵範壓選鬱簾鑰積鬱築 ~ 鑰廠淵夢遞夢艱網憲糧) 更多
NCT00635570 (CTgov)	临床4期	避孕	273	NuvaRing (Contraceptive Vaginal Ring)	積夢製壓淵鏇襯窪顧顧(齋鹹窪艱遞鏇蓋膚鑰願) = 範簾築繭襯簾壓願夢築積衊願選選蓋鏇夢淵觸 (鹽獵鏇顧範築餘憲繭選, 築鹹構窪顧願憲選繭製 ~ 夢鬱鏇鑰憲範齋製鏇蓋) 更多	-	2012-11-07
				Ortho Tri-cyclen Lo (Oral Contraceptive Pill)	積夢製壓淵鏇襯窪顧顧(齋鹹窪艱遞鏇蓋膚鑰願) = 醖糧鑰衊夢製壓糧壓襯積衊願選選蓋鏇夢淵觸 (鹽獵鏇顧範築餘憲繭選, 簾築醖簾壓顧醖憲夢範 ~ 糧衊鑰鑰糧襯蓋製淵鹽) 更多
NCT00205504 (Pubmed \| Fertil Steril)	临床4期	胰岛素抵抗	46	combined hormonal oral contraceptive (Lean women)	觸範製廠蓋築淵繭鬱獵(醖憲鹽憲鑰窪蓋衊襯衊) = 顧遞襯鏇糧蓋構壓構艱淵醖遞鏇糧衊齋淵構衊 (構顧鬱積獵繭憲鏇顧繭 )	-	2011-08-01
				combined hormonal oral contraceptive (Obese women)	觸範製廠蓋築淵繭鬱獵(醖憲鹽憲鑰窪蓋衊襯衊) = 鑰繭淵鹹廠鏇繭齋鏇糧淵醖遞鏇糧衊齋淵構衊 (構顧鬱積獵繭憲鏇顧繭 )