The Sponsor is developing a progestin-only contraceptive transdermal system (patch).
The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated.
The study patch is a transdermal system that contains the active ingredient, progestin.

Start Date01 Dec 2024

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

NCT06048536 / CompletedPhase 2

An Open-label, Phase II, Dose-finding Study of Three Dose Strengths of MR-130A-01 Contraceptive Transdermal Patch in Healthy Pre-menopausal Women

A single-center, randomized, open-label, parallel-group, multi-arm, phase II clinical trial in healthy women aged 18 to 35 years who have a documented ovulatory cycle prior to randomization.

Start Date22 Dec 2023

Sponsor / Collaborator

Viatris, Inc.

EUCTR2022-003219-26-DE / Not yet recruitingPhase 2

An open-label, phase II, dose-finding study of three dose strengths of MR-130A-01 contraceptive transdermal patch containing norelgestromin (NGMN) in healthy pre-menopausal women

Start Date10 Jan 2023

Sponsor / Collaborator

Mylan Pharmaceuticals, Inc.

100 Clinical Results associated with Norelgestromin

100 Translational Medicine associated with Norelgestromin

100 Patents (Medical) associated with Norelgestromin

126

Literatures (Medical) associated with Norelgestromin

01 Sep 2024·Contraception

Use of serum evaluation of contraceptive and ovarian hormones to assess reduced risk of pregnancy among women presenting for emergency contraception in a multicenter clinical trial

Article

Author: Blithe, Diana L ; Westhoff, Carolyn L ; Teal, Stephanie ; Jensen, Jeffrey T ; Archer, David F ; Schreiber, Coutney A ; Thomas, Michael ; Brown, Jill ; Edelman, Alison

OBJECTIVESTo evaluate ovulation risk among women enrolling in an emergency contraception (EC) study by measuring contraceptive steroids and ovarian hormones.STUDY DESIGNWe used standard chemiluminescent assays to evaluate endogenous hormones (estradiol, progesterone, follicle stimulating hormone, luteinizing hormone) and liquid chromatography-tandem triple quadrupole mass spectrometry to simultaneously analyze concentrations of ethinylestradiol, dienogest, norelgestromin (NGMN), norethindrone (NET), gestodene, levonorgestrel (LNG), etonogestrel (ENG), segesterone acetate, medroxyprogesterone acetate (MPA), and drospirenone in serum samples obtained at the time of enrollment in a recent study comparing oral ulipristal acetate and LNG EC in women with weight ≥80 kg reporting no recent use of hormonal contraception.RESULTSWe enrolled 532 and obtained a valid baseline blood sample from 520 women. Of these, 117 (22.5%) had detectable concentrations of progestin (MPA [n = 58, 11.2%], LNG [50, 9.6%], ENG [11, 2.1%], NET [5, 0.96%], NGMN [3, 0.06%], or drospirenone [1, 0.02%]). LNG was co-detected in all three participants with samples containing NGMN. Multiple progestins were detected in eight other women: ENG/MPA (1), ENG/LNG (2), and MPA/LNG (5). Samples from 55 (10.6%) had concentrations of one or more progestin considered above the minimum level for contraceptive (MPA ≥ 0.1 ng/mL, n = 19; NGMN/LNG ≥ 0.2 ng/mL, n = 31; ENG ≥ 0.09 ng/mL, n = 8; NET ≥ 0.35 ng/mL, n = 4). We detected concentrations of serum progesterone ≥ 3 ng/mL, indicative of luteal phase (postovulation) status, in an additional 194 (37.3%) samples.CONCLUSIONSMore than one-third of enrolled in our clinical trial of oral EC had evidence of prior ovulation at the time of enrollment. Additionally, about 23% had evidence of recent use of hormonal contraception. These results would have decreased the expected risk of pregnancy in the study.IMPLICATIONSMany participants in a recent clinical trial of oral emergency contraception did not appear to be at risk for pregnancy or would not have benefited from intervention due to cycle timing. Investigators should consider the effects of these findings on expected pregnancy rates when determining sample size in future EC clinical trials, particularly when using noninferiority designs or historical controls.

01 Sep 2024·Reproductive BioMedicine Online

Effect of various contraceptives on oocyte yield and maturation in patients undergoing planned oocyte cryopreservation

Article

Author: Hernandez-Nieto, Carlos ; Mejia-Fernandez, Loreli ; Lee, Joseph ; Siddiqui, Saher ; Mukherjee, Tanmoy ; Copperman, Alan B ; Slifkin, Richard ; Alkon-Meadows, Tamar

RESEARCH QUESTIONDo the various forms of hormonal and non-hormonal contraceptives have any association with ovarian stimulation outcomes, such as oocyte yield and maturation, in patients undergoing planned oocyte cryopreservation (POC)?DESIGNThis retrospective cohort study included all patients who underwent POC cycles between 2011 and 2023. The use of types of contraception before a POC cycle was recorded. The study evaluated the median number of cumulus-oocyte complexes obtained after vaginal oocyte retrieval and the proportion of metaphase II oocytes that underwent vitrification among all the cohorts.RESULTSA total of 4059 oocyte freezing cycles were included in the analysis. Eight types of contraceptive method were recognized in patients undergoing ovarian stimulation: intrauterine device (IUD), copper (n = 84); IUD, levonorgestrel low dose (<52 mg) (n = 37); IUD, levonorgestrel (n = 192); subdermal etonogestrel implant (n = 14); injectable medroxyprogesterone acetate (n = 11); etonogestrel vaginal ring (n = 142); combined oral contraceptive pills (n = 2349); and norelgestromin transdermal patch (n = 10). The control group included patients not using contraceptives or using barrier or calendar methods (n = 1220). Among all the cohorts the median number of cumulus-oocyte complexes retrieved during oocyte retrieval was comparable (P = 0.054), and a significant difference in oocyte maturity rate with median number of vitrified oocytes was found (P = 0.03, P < 0.001, respectively). After adjusting for confounders a multivariate analysis found no association between the type of contraceptive and proportion of metaphase II oocytes available for cryopreservation.CONCLUSIONSAmong the various forms of contraception, none was shown to have an adverse association with oocyte yield or maturation rate in patients undergoing POC.

01 Oct 2023·Contraception

Development and validation of an expanded panel of progestins using liquid chromatography-tandem triple quadrupole mass spectrometry to monitor protocol compliance in hormonal contraceptive pharmacokinetic/pharmacodynamic studies

Article

Author: Waites, Bethany T ; Jensen, Jeffrey T ; Boniface, Emily R ; McCrimmon, Sara ; Erikson, David W ; Blue, Steven

We developed and validated the use of ultra-high-performance liquid chromatography-heated electrospray ionization-tandem triple quadrupole mass spectrometry to simultaneously analyze serum concentrations of ethinylestradiol, dienogest, norelgestromin, norethindrone, gestodene, levonorgestrel, etonogestrel, segesterone acetate, medroxyprogesterone acetate, and drospirenone. The calibration range for all targets was 0.009-10 ng/mL, with lower limit of quantification of 0.009 ng/mL for all analytes except gestodene (0.019 ng/mL). We used our assay to check compliance among participants in a clinical trial, confirmed the use of drospirenone in 11 of 13 study participants, and evidence of noncompliant progestins in 2 (levonorgestrel = 1, norethindrone = 1). We conclude that this approach provides an accurate method to check protocol compliance in contraceptive clinical trials. IMPLICATIONS: The availability of a liquid chromatography-tandem triple quadrupole mass spectrometry multiprogestin analysis panel for simultaneous evaluation of the most common contraceptive steroids approved worldwide could improve monitoring of compliance and protocol adherence in clinical trials.

News (Medical) associated with Norelgestromin

11 May 2023

·www.pharmaceutical-technology.com

FDA AdCom votes unanimously in favour of OTC oral contraceptive

Akosua Mireku @AkosuaMireku1 Women laying on sofa holding pills. Credit: Vertigo3d via Getty Images A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Norelgestromin in Female Contraception GlobalData Reports LOA and PTSR Model - (Clotrimazole + Diclofenac Sodium) in Vulvovaginal Candidiasis GlobalData View all Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. This joint committee decision came from Nonprescription Drugs, and the Obstetrics, Reproductive and Urologic Drugs FDA divisions was based on meetings conducted on 9 – 10 May, was based on data presented from the Phase III ACCESS trial (NCT04112095) that assessed adherence to a dosing regimen for Opill, an oral contraceptive. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily. Progestin mimics progesterone’s effects in the body, inhibiting ovulation and reducing the amount and stretchiness of cervical mucus to make it more hostile for sperm. In May 2022, Perrigo , a company that specializes in OTC health and wellness products completed an acquisition of HRA Pharma. Now via HRA Pharma, Perrigo which is also the largest OTC store brand, aims to make Opill available OTC to all users of reproductive age, including adolescents. If approved, the Opill will be the first FDA-approved oral contraceptive available OTC in the US. Following the 2022 US Supreme Court decision to overturn Roe v Wade , several political events have heavily impacted women’s reproductive rights and access to relevant medication. In January, the FDA modified the Risk Evaluation and Mitigation Strategies (REMS) program for Mifeprex (mifepristone), used for medication abortion, which eased its dispensation to consumers. But this was followed by a lower court decision that limited access to Mifeprex, which was later overturned by the US Supreme Court ruling upheld the FDA’s rules governing the sale of the drug. During the recent clinical study, HRA Pharma found that adherence to the daily dosage regimen was mixed amongst participants, triggering uncertainty amongst some panel members that this could be a result of a misunderstanding of the dose regimen or other factors. However, panel member, Jolie Haun, PhD, a research health scientist at the Veterans Health Administration pointed out that any concerns about adherence may not be relevant as most patients receive an annual prescription and are left to their own devices to maintain adherence in the current prescription model. During the AdCom, Dr. Leslie Walker-Harding, the chair of the Department of Paediatrics for the University of Washington said, “Any amount of delay [in access to these oral contraceptives] during a time when people have less access to primary care providers post-pandemic than they ever have is really causing further harm to adolescents and others who don’t have access to these medications that could help them prevent an unwanted pregnancy”. Haun said, “I believe that this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies”. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Phase 3AcquisitionDrug Approval

26 Feb 2021

·www.biospace.com

Amneal Receives Approval for Generic Version of Ortho Evra®

Feb. 26, 2021 11:02 UTC Company granted 180 days of exclusivity under FDA Competitive Generic Therapy (CGT) approval pathway Expects to begin commercialization activities March 1, 2021 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System. In conjunction with its approval, Amneal received a Competitive Generic Therapy (CGT) designation by the FDA and has been granted 180 days of exclusivity. Amneal’s Norelgestromin and Ethinyl Estradiol Transdermal System is the generic version of the reference listed drug (“RLD”) Ortho Evra® and will be marketed under the proprietary name Zafemy™. Zafemy is a 12.5 cm2 patch indicated for the prevention of pregnancy in women with a Body Mass Index of less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Zafemy may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg). The Company expects to begin commercialization activities on March 1, 2021. “Today’s approval is a significant milestone for patients and our company,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Zafemy will provide patients with another option to the one equivalent product - Xulane®, manufactured by Mylan - currently on the market. It also demonstrates the continued successful execution of our strategy to develop and commercialize complex generics and represents the 10th of 15 high-value complex products we expect to launch before August 2021.” According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Xulane® for the 12 months ended December 2020 were approximately $332 million. “Zafemy is our fifth transdermal product approval and utilizes our extensive in-house expertise in Matrix-based as well as Hydrogel-based patches,” continued Mssrs. Patel. “We continue to focus our R&D capabilities as well as the power of our integrated supply chain on bringing more complex products to market faster and more cost efficiently.” The RLD Ortho Evra® has been discontinued, and according to the FDA announcement of discontinuation published in the Federal Register, the product was not discontinued or withdrawn for safety or efficacy reasons. Xulane® is the only other equivalent to Ortho Evra® currently available on the market. The drug carries a boxed warning regarding cigarette smoking and serious cardiovascular events. Zafemy is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC), the labeling says. Zafemy is also contraindicated for use in women with a Body Mass Index greater than 30 kg/m2. Women with a BMI greater than 30 kg/m2 may have a higher risk of venous thromboembolic events compared with women with a lower BMI. The most frequent adverse reactions reported during clinical trials (≥ 5%) were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. See Package Insert (PI) for full prescribing information including boxed warning: About Amneal Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States. Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders. The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit . Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected operating results and financial performance; impact of planned acquisitions and dispositions; the Company’s strategy for growth; product development; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic; the impact of global economic conditions; our ability to successfully develop, license, acquire and commercialize new products on a timely basis; our ability to obtain exclusive marketing rights for our products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify and make acquisitions of or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. View source version on businesswire.com: Contacts Tasos Konidaris EVP, Chief Financial Officer invest@amneal.com Source: Amneal Pharmaceuticals, Inc. View this news release online at:

Generic DrugBiosimilarAcquisition

100 Deals associated with Norelgestromin

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KEGG	Wiki	ATC	Drug Bank
D05205	Norelgestromin	G02B	DB06713

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Contraception	-	-	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 3	US	Mylan Pharmaceuticals, Inc.	01 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01044056 (P06650, CTgov)	Phase 4	Contraception	24	Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets (Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill)	tkzzsrtfjr(foizautqqv) = tzarwmyans hifyoghocy (tabuubxoob, gtuhdtriew - igovteqlus) View more	-	31 Mar 2010
				ethinylestradiol patch oral contraceptive patch+norelgestrominum (Norelgestrominum and Ethinylestradiol Contraceptive Patch)	tkzzsrtfjr(foizautqqv) = vauzrnhnsq hifyoghocy (tabuubxoob, ueljyhiuij - gwhbsermwe) View more

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