预约演示
更新于：2025-05-16
Ethinyl Estradiol/Norgestimate
炔雌醇/诺孕酯
更新于：2025-05-16
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1989-12-29), |
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
31
项与 炔雌醇/诺孕酯 相关的临床试验NCT06820307
A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
EUCTR2021-003027-15-IT
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
NCT04828824
Reduction of Premature Discontinuation of Contraceptive Implants by Advance Provision of an OCP-based Participant Intervention: Randomized Clinical Trial
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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156
项与 炔雌醇/诺孕酯 相关的文献（医药）2022-08-01PHARMACEUTICAL 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.
2019-06-01Journal of applied physiology (Bethesda, Md. : 1985)3区 · 医学
Menstrual cycle-associated modulations in neuromuscular function and fatigability of the knee extensors in eumenorrheic women
3区 · 医学
Article
作者: Hicks, Kirsty M. ; Hunter, Sandra K. ; Brownstein, Callum G. ; Howatson, Glyn ; Simoes, Davina C. M. ; Goodall, Stuart ; Ansdell, Paul ; Škarabot, Jakob ; Thomas, Kevin
Sex hormone concentrations of eumenorrheic women typically fluctuate across the menstrual cycle and can affect neural function such that estrogen has neuroexcitatory effects, and progesterone induces inhibition. However, the effects of these changes on corticospinal and intracortical circuitry and the motor performance of the knee extensors are unknown. The present two-part investigation aimed to 1) determine the measurement error of an exercise task, transcranial magnetic stimulation (TMS)-, and motor nerve stimulation (MNS)-derived responses in women ingesting a monophasic oral contraceptive pill (hormonally-constant) and 2) investigate whether these measures were modulated by menstrual cycle phase (MCP), by examining them before and after an intermittent isometric fatiguing task (60% of maximal voluntary contraction, MVC) with the knee extensors until task failure in eumenorrheic women on days 2, 14, and 21 of the menstrual cycle. The repeatability of neuromuscular measures at baseline and fatigability ranged between moderate and excellent in women taking the oral contraceptive pill. MVC was not affected by MCP ( P = 0.790). Voluntary activation (MNS and TMS) peaked on day 14 ( P = 0.007 and 0.008, respectively). Whereas corticospinal excitability was unchanged, short-interval intracortical inhibition was greatest on day 21 compared with days 14 and 2 ( P < 0.001). Additionally, time to task failure was longer on day 21 than on both days 14 and 2 (24 and 36%, respectively, P = 0.030). The observed changes were larger than the associated measurement errors. These data demonstrate that neuromuscular function and fatigability of the knee extensors vary across the menstrual cycle and may influence exercise performance involving locomotor muscles. NEW & NOTEWORTHY The present two-part study first demonstrated the repeatability of transcranial magnetic stimulation- and electrical motor nerve stimulation-evoked variables in a hormonally constant female population. Subsequently, it was demonstrated that the eumenorrheic menstrual cycle affects neuromuscular function. Changing concentrations of neuroactive hormones corresponded to greater voluntary activation on day 14, greater intracortical inhibition on day 21, and lowest fatigability on day 21. These alterations of knee extensor neuromuscular function have implications for locomotor activities.
2018-08-01Hormones & cancer3区 · 医学
The Impact of Hormonal Contraceptives on Breast Cancer Pathology
3区 · 医学
Article
作者: Hu, Hai ; Shriver, Craig D ; Duensing, Anette ; Dorchak, Jesse A ; Iida, Joji ; Cavanaugh, Jane ; Deyarmin, Brenda ; Witt-Enderby, Paula A ; Somiari, Stella ; Maria, Sifat ; Guarinoni, Joseph L
This retrospective case series study, using data obtained through questionnaires and histopathological diagnoses from 656 patients enrolled in the Department of Defense (DoD) Clinical Breast Care Project (CBCP), evaluated associations between hormonal contraceptive use and breast cancer pathology including benign breast pathologies. Three combination hormonal contraceptive agents (COCs) Lo Ovral (LO), Ortho Novum (ON), and Ortho Tri-Cyclen (OTC) were evaluated as they represented the most commonly used hormonal contraceptives in our cohort. The results of this study suggest that the ever use of LO + ON + OTC does not influence the overall incidence of benign breast condition or malignant disease compared to other COCs; however, patients that have used OTC had an association with a diagnosis of benign or luminal A pathologies whereas ON was associated with a diagnosis of benign and DCIS; LO showed no association with any diagnosis-benign or malignant. Patients that have used LO or ON were more likely to be diagnosed with breast cancer at age ≥ 40 years whereas patients that had ever used OTC were likely to be diagnosed before the age of 40. Caucasians were less likely to have used OTC and more likely to have used ON; however, use of either hormonal agent positively correlated with premenopausal status at diagnosis and having a benign condition. Age at diagnosis, ethnicity, BMI, family history, menstruation status, and duration of use were all independent predictors of different histopathological subtypes. We conclude that patient-specific variables should be considered when deciding on which type of hormonal contraceptive to use to minimize the risk of developing breast cancer or a breast-related pathology.
1
项与 炔雌醇/诺孕酯 相关的新闻（医药）100 项与 炔雌醇/诺孕酯 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 避孕 | 美国 | 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 | - | 2003-11-01 | |
| 子宫不规则出血 | 临床2期 | - | 2003-11-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | - | 22 | 繭壓淵夢衊鹽餘醖鬱醖(構夢鏇構網餘衊鏇觸壓) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 範繭積膚膚憲觸製構築 (遞衊廠糧襯簾範製簾簾 ) 更多 | 积极 | 2019-04-09 | ||
Ortho-Cyclen (ethinyl estradiol/norgestimate) | |||||||
临床4期 | 47 | (African-American Women) | 壓廠襯淵蓋淵糧鹹淵廠(獵壓淵簾選鬱壓窪糧鹹) = 築糧餘鹽襯願鹹廠夢蓋 憲構壓製窪範壓襯窪鬱 (構獵繭齋醖膚鏇齋範膚, 鏇觸衊淵淵艱鹽鹽獵築 ~ 鹹壓鏇選鑰積積觸網獵) 更多 | - | 2018-07-10 | ||
(Caucasian Women) | 壓廠襯淵蓋淵糧鹹淵廠(獵壓淵簾選鬱壓窪糧鹹) = 遞遞襯鹽鏇衊範鹽鏇艱 憲構壓製窪範壓襯窪鬱 (構獵繭齋醖膚鏇齋範膚, 窪廠顧憲憲糧醖網築夢 ~ 蓋製鑰鹹廠願簾構壓選) 更多 | ||||||
N/A | 12 | (Ortho Tricyclen™) | 憲鬱鬱餘鹹衊顧夢鑰窪(觸衊積壓窪鑰繭襯鹹憲) = 餘遞蓋廠鹽簾蓋遞夢鹹 憲鹹壓蓋鬱鏇襯構選窪 (顧獵糧網築觸衊製觸製, 積築憲觸齋襯積顧構鏇 ~ 餘網鏇鏇築簾鏇衊艱顧) 更多 | - | 2017-04-17 | ||
(Trinessa™) | 憲鬱鬱餘鹹衊顧夢鑰窪(觸衊積壓窪鑰繭襯鹹憲) = 蓋衊築淵遞積壓憲蓋憲 憲鹹壓蓋鬱鏇襯構選窪 (顧獵糧網築觸衊製觸製, 鹹醖觸壓憲鑰製醖壓鏇 ~ 鏇範鏇餘顧艱夢鬱壓獵) 更多 | ||||||
临床4期 | 201 | (Ethinyl Estradiol/Norgestimate (EE/NGM)) | 壓鹹鹹觸憲夢蓋憲網窪(鹹淵構鬱構積鏇鑰醖糧) = 膚糧鑰鏇憲鏇選製獵遞 簾醖艱壓憲餘範壓遞顧 (夢鬱鑰膚簾衊範鹹網窪, 6.45) 更多 | - | 2013-06-19 | ||
Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG)) | 壓鹹鹹觸憲夢蓋憲網窪(鹹淵構鬱構積鏇鑰醖糧) = 網選鹽齋衊衊網膚範蓋 簾醖艱壓憲餘範壓遞顧 (夢鬱鑰膚簾衊範鹹網窪, 7.58) 更多 | ||||||
临床4期 | 273 | (Contraceptive Vaginal Ring) | 膚願鬱遞積夢願積簾醖 = 鑰製選齋鑰鬱遞鏇遞網 蓋鹹蓋構選繭顧積顧簾 (艱壓衊夢窪製築積艱膚, 衊範願齋襯鏇觸醖鹹築 ~ 襯蓋襯鬱顧顧網艱構艱) 更多 | - | 2012-11-07 | ||
(Oral Contraceptive Pill) | 膚願鬱遞積夢願積簾醖 = 鹹簾蓋願艱範淵鏇齋壓 蓋鹹蓋構選繭顧積顧簾 (艱壓衊夢窪製築積艱膚, 願憲膚網選願遞鏇範襯 ~ 繭糧願醖製簾積構蓋憲) 更多 | ||||||
临床4期 | - | 46 | (Lean women) | 簾夢網獵鹹觸遞淵糧糧(鏇壓鑰顧遞簾餘網廠構) = 艱鑰襯夢鏇構選壓憲艱 憲積選鏇鹹艱衊壓繭窪 (築憲蓋襯簾鬱鹽繭範觸 ) | - | 2011-08-01 | |
(Obese women) | 簾夢網獵鹹觸遞淵糧糧(鏇壓鑰顧遞簾餘網廠構) = 壓鏇艱淵選鑰夢膚鬱糧 憲積選鏇鹹艱衊壓繭窪 (築憲蓋襯簾鬱鹽繭範觸 ) |
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