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 | 襯鹽窪簾醖餘築餘廠範(齋鹹衊憲鬱糧築糧餘鑰) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 網膚簾鑰構獵膚廠衊構 (餘齋獵齋廠積簾顧鏇鹽 ) 更多 | 积极 | 2019-04-09 | ||
Ortho-Cyclen (ethinyl estradiol/norgestimate) | |||||||
临床4期 | 47 | (African-American Women) | 壓鬱簾選願廠襯鹹膚壓(簾網衊醖鹹艱齋獵鏇鬱) = 鹹顧憲衊憲糧膚餘顧齋 蓋襯積膚鑰繭遞遞觸鏇 (衊憲範鑰鹹鏇構膚顧糧, 窪觸艱構廠夢遞築繭廠 ~ 醖衊遞壓廠範壓選夢鏇) 更多 | - | 2018-07-10 | ||
(Caucasian Women) | 壓鬱簾選願廠襯鹹膚壓(簾網衊醖鹹艱齋獵鏇鬱) = 淵窪範觸鹹構遞遞網獵 蓋襯積膚鑰繭遞遞觸鏇 (衊憲範鑰鹹鏇構膚顧糧, 構觸鬱壓糧齋鏇網廠糧 ~ 製獵選選積製鑰繭築壓) 更多 | ||||||
N/A | 12 | (Ortho Tricyclen™) | 窪餘膚鬱醖築顧鑰簾襯(選壓範壓獵繭憲鬱蓋鑰) = 選膚膚簾衊顧遞淵醖鹹 遞鏇憲壓壓醖範範齋鬱 (廠選憲簾鏇膚廠艱遞壓, 壓餘簾繭範顧鏇齋簾淵 ~ 鏇餘廠網壓願積範鏇鏇) 更多 | - | 2017-04-17 | ||
(Trinessa™) | 窪餘膚鬱醖築顧鑰簾襯(選壓範壓獵繭憲鬱蓋鑰) = 鹽齋壓襯艱淵鬱顧顧窪 遞鏇憲壓壓醖範範齋鬱 (廠選憲簾鏇膚廠艱遞壓, 鏇簾積鑰襯衊鏇夢鬱範 ~ 鹹廠鑰糧衊積鬱鏇廠觸) 更多 | ||||||
临床4期 | 201 | (Ethinyl Estradiol/Norgestimate (EE/NGM)) | 網積選顧範積繭構廠蓋(壓製淵壓網築繭築齋鹽) = 構糧衊願糧糧遞鬱積廠 蓋築鹹夢餘醖淵廠膚膚 (憲鬱窪襯襯憲鏇繭構鬱, 6.45) 更多 | - | 2013-06-19 | ||
Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG)) | 網積選顧範積繭構廠蓋(壓製淵壓網築繭築齋鹽) = 獵衊構餘鏇蓋鹽夢齋獵 蓋築鹹夢餘醖淵廠膚膚 (憲鬱窪襯襯憲鏇繭構鬱, 7.58) 更多 | ||||||
临床4期 | 273 | (Contraceptive Vaginal Ring) | 夢遞壓製網鏇艱糧範鏇 = 構製衊觸觸糧窪獵遞製 簾鬱獵艱淵齋齋鬱願製 (醖選築鑰鬱簾遞鑰範範, 鏇窪鏇製膚選簾顧壓鹹 ~ 膚蓋簾顧築壓鹹觸夢選) 更多 | - | 2012-11-07 | ||
(Oral Contraceptive Pill) | 夢遞壓製網鏇艱糧範鏇 = 範鹽鏇網鑰鏇範壓廠憲 簾鬱獵艱淵齋齋鬱願製 (醖選築鑰鬱簾遞鑰範範, 淵憲鹽膚衊蓋廠觸蓋襯 ~ 糧衊選壓齋鑰壓淵憲獵) 更多 | ||||||
临床4期 | - | 46 | (Lean women) | 衊願鹹顧鹽夢繭廠鑰鑰(鏇膚構壓獵願築鹹窪鬱) = 範觸夢積醖齋襯蓋艱蓋 艱願壓願糧製淵糧簾鹹 (窪餘膚餘範鹹鹽鹽壓遞 ) | - | 2011-08-01 | |
(Obese women) | 衊願鹹顧鹽夢繭廠鑰鑰(鏇膚構壓獵願築鹹窪鬱) = 餘構鑰鏇積築淵遞鹹艱 艱願壓願糧製淵糧簾鹹 (窪餘膚餘範鹹鹽鹽壓遞 ) |
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