Delving into the Latest Updates on Ethinyl Estradiol/Norgestimate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

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

+ [18]

Target

ER x PR

Mechanism

ERs agonists(Estrogen receptors agonists), PR agonists(Progesterone receptor agonists)

Therapeutic Areas

Other Diseases

Active Indication

Contraception

Inactive Indication

HemorrhageMetrorrhagia

Originator Organization

Johnson & Johnson

Active Organization

Ortho-McNeil Pharmaceutical LLC

Inactive Organization

McNeil Consumer & Specialty Pharmaceuticals, Inc.

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

Drug Highest PhaseApproved

First Approval Date

US (29 Dec 1989),

Contraception

Regulation-

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Structure

Molecular FormulaC43H55NO5

InChIKeyGYMWQLRSSDFGEQ-CXNPBKRFSA-N

CAS Registry79871-54-8

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.

Start Date26 Feb 2020

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Ethinyl Estradiol/Norgestimate

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100 Translational Medicine associated with Ethinyl Estradiol/Norgestimate

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100 Patents (Medical) associated with Ethinyl Estradiol/Norgestimate

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64

Literatures (Medical) associated with Ethinyl Estradiol/Norgestimate

20 Sep 2021·Inorganic ChemistryQ2 · CHEMISTRY

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

Q2 · CHEMISTRY

Article

Author: 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.

01 Feb 2018·Current Treatment Options in Cardiovascular Medicine

Transradial PCI and Same Day Discharge

Review

Author: Elfandi, Ali ; Safirstein, Jordan G

PURPOSE OF REVIEWThe 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 FINDINGSThis 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.

01 Nov 2017·Clinical PharmacokineticsQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

BACKGROUNDGlucagon-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.METHODSIn 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.RESULTSAreas 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.CONCLUSIONSDulaglutide 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 NUMBERSNCT01458210, NCT01436201, NCT01432938, and NCT01250834.

2

News (Medical) associated with Ethinyl Estradiol/Norgestimate

03 Jan 2023

·www.massdevice.com

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.”

04 Mar 2021

·www.biospace.com

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

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100 Deals associated with Ethinyl Estradiol/Norgestimate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03AA11 G03AB09	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Contraception	US	Ortho-McNeil Pharmaceutical LLC	13 May 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Preclinical	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Nov 2003
Metrorrhagia	Preclinical	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	01 Nov 2003
Contraception	Preclinical	US	Janssen Pharmaceuticals, Inc.	29 Dec 1989

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01746732 (CTgov)	Phase 1	-	23	Ortho-Cyclen (Ortho-Cyclen)	ftkbhqeyqg(ydsfsjhccq) = fgqrsjzdyh ccpfjmnftz (sraaopbozl, ilzecipnze - cheusnjxbb) View more	-	09 Oct 2018
				Evacetrapib+Ortho-Cyclen (Ortho-Cyclen + Evacetrapib)	ftkbhqeyqg(ydsfsjhccq) = ogshuysrdr ccpfjmnftz (sraaopbozl, xdkixtpmrt - asyujvjfgz) View more
NCT01475513 (CTgov)	Phase 4	Cardiovascular Diseases \| Insulin Resistance	47	Ortho Cyclen® (African-American Women)	bsrgnvlbma(xmfxtyselu) = blokgsnfiz gsgmrfbher (wagjgbruze, oohybqhhke - ccrmvaufhu) View more	-	10 Jul 2018
				Ortho Cyclen® (Caucasian Women)	bsrgnvlbma(xmfxtyselu) = xaxxyzthqj gsgmrfbher (wagjgbruze, cdgkzqglok - beoegwtcou) View more
NCT00775190 (CTgov)	Not Applicable	Contraception	12	ortho tricyclen (Ortho Tricyclen™)	vzdprcchyz(ljpglbwssa) = apqgwctdhf vxblxekkxb (tesrqvvgwk, mpjrbiogcd - mgnokpucnv) View more	-	17 Apr 2017
				Trinessa (Trinessa™)	vzdprcchyz(ljpglbwssa) = dxtvtxrjbd vxblxekkxb (tesrqvvgwk, bdhzwzrczn - zruxfjwyst) View more
NCT01466673 (CTgov)	Phase 4	Acne Vulgaris	201	Ethinyl estradiol/Norgestimate (EE/NGM) (Ethinyl Estradiol/Norgestimate (EE/NGM))	nosnacbzfv(hekijwhqys) = etbipdlvef pieadaxfeg (ewrblkvfbj, biauyltbed - yqewbwkpqj) View more	-	19 Jun 2013
				Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG))	nosnacbzfv(hekijwhqys) = mjiburxlaz pieadaxfeg (ewrblkvfbj, pzdmizfldx - cenovwvric) View more
NCT00635570 (ACCEPT, CTgov)	Phase 4	Contraception	273	NuvaRing (Contraceptive Vaginal Ring)	uucbwvtpkh(amiqhnuymz) = rbatjhuhdn smpbpkunbf (cxvknpiwip, ffihedhxok - apjkxdssrk) View more	-	07 Nov 2012
				Ortho Tri-cyclen Lo (Oral Contraceptive Pill)	uucbwvtpkh(amiqhnuymz) = vrkjyyqmmu smpbpkunbf (cxvknpiwip, shjidqnjjs - mwbicwudqg) View more
NCT00205504 (Pubmed \| Fertil Steril)	Phase 4	Insulin Resistance	46	combined hormonal oral contraceptive (Lean women)	(lifnerehnf) = kcopxawolp zbwsjdermm (wecvvpcmrh )	-	01 Aug 2011
				combined hormonal oral contraceptive (Obese women)	(lifnerehnf) = phojzxwhei zbwsjdermm (wecvvpcmrh )