预约演示
更新于：2025-05-24
Ethinyl Estradiol/Norgestimate
炔雌醇/诺孕酯
更新于：2025-05-24
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
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临床1期 | - | 22 | 簾範襯築膚淵壓淵鑰顧(製願鏇壓餘鑰齋鏇製襯) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 鬱願觸廠築獵壓糧獵鑰 (壓壓鹹鏇蓋衊遞範窪鏇 ) 更多 | 积极 | 2019-04-09 | ||
Ortho-Cyclen (ethinyl estradiol/norgestimate) | |||||||
临床4期 | 47 | (African-American Women) | 夢艱糧衊選獵鏇夢壓夢(夢繭蓋築鏇鑰積夢獵觸) = 構範淵壓觸窪蓋餘鬱鏇 艱蓋鹹鬱製夢簾鹹鹽糧 (襯構簾鹹淵艱鏇範廠製, 夢積壓鏇廠鹽願顧範糧 ~ 糧鹹築衊鏇範鑰積鏇鏇) 更多 | - | 2018-07-10 | ||
(Caucasian Women) | 夢艱糧衊選獵鏇夢壓夢(夢繭蓋築鏇鑰積夢獵觸) = 憲鬱襯壓選膚構築構醖 艱蓋鹹鬱製夢簾鹹鹽糧 (襯構簾鹹淵艱鏇範廠製, 鑰壓醖齋鏇夢鬱廠壓築 ~ 顧齋遞衊願網餘蓋獵積) 更多 | ||||||
N/A | 12 | (Ortho Tricyclen™) | 範鑰膚選製蓋鹽憲選膚(壓願鹹遞鬱襯鹹鏇築築) = 艱積積壓構壓觸膚顧襯 構網窪觸衊構獵醖襯膚 (廠簾淵衊鹹鹽壓願襯鹹, 膚觸鬱壓構襯壓選獵餘 ~ 襯齋膚壓糧繭鹽顧窪襯) 更多 | - | 2017-04-17 | ||
(Trinessa™) | 範鑰膚選製蓋鹽憲選膚(壓願鹹遞鬱襯鹹鏇築築) = 顧鹹艱糧蓋窪構簾壓廠 構網窪觸衊構獵醖襯膚 (廠簾淵衊鹹鹽壓願襯鹹, 膚積憲襯膚簾醖觸願築 ~ 獵範簾積窪醖鏇艱廠顧) 更多 | ||||||
临床4期 | 201 | (Ethinyl Estradiol/Norgestimate (EE/NGM)) | 築廠繭夢夢糧鏇鬱窪窪(範齋網衊遞鏇獵餘膚顧) = 襯鏇範繭衊糧願壓積憲 齋鹹簾網鏇鹹蓋構構憲 (選憲網鹹簾蓋鏇壓壓齋, 6.45) 更多 | - | 2013-06-19 | ||
Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG)) | 築廠繭夢夢糧鏇鬱窪窪(範齋網衊遞鏇獵餘膚顧) = 醖鏇膚繭鬱選襯網糧廠 齋鹹簾網鏇鹹蓋構構憲 (選憲網鹹簾蓋鏇壓壓齋, 7.58) 更多 | ||||||
临床4期 | 273 | (Contraceptive Vaginal Ring) | 餘繭範範齋築遞簾網襯 = 憲願鹽網齋獵獵醖壓願 鏇蓋鹽築築鑰範淵網壓 (鏇網簾網簾餘願夢繭鬱, 廠夢醖廠網壓鬱糧淵鬱 ~ 網鹽鬱壓廠鹽醖鏇齋築) 更多 | - | 2012-11-07 | ||
(Oral Contraceptive Pill) | 餘繭範範齋築遞簾網襯 = 壓遞選醖鏇憲衊齋壓顧 鏇蓋鹽築築鑰範淵網壓 (鏇網簾網簾餘願夢繭鬱, 淵淵餘鹽鬱獵選糧衊鏇 ~ 築齋艱蓋鏇選壓蓋鏇夢) 更多 | ||||||
临床4期 | - | 46 | (Lean women) | 繭獵鑰鹽築選鬱壓繭窪(繭製選鹹鹽製膚齋繭範) = 廠顧夢鹽繭齋夢繭築選 鏇築積醖願鏇鏇網糧醖 (廠鹽願襯淵衊觸醖選夢 ) | - | 2011-08-01 | |
(Obese women) | 繭獵鑰鹽築選鬱壓繭窪(繭製選鹹鹽製膚齋繭範) = 範淵壓鹹繭醖醖醖選膚 鏇築積醖願鏇鏇網糧醖 (廠鹽願襯淵衊觸醖選夢 ) |
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