预约演示
更新于：2026-02-27
Ethinyl Estradiol/Norgestimate
炔雌醇/诺孕酯
更新于：2026-02-27
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
33
项与 炔雌醇/诺孕酯 相关的临床试验NCT07074327
Phase 1, Open-label Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Subjects
NCT06820307
A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
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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111
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.
2020-08-01Hormones and behavior3区 · 医学
Use of the birth control pill affects stress reactivity and brain structure and function
3区 · 医学
Article
作者: Nafissa Ismail ; Rupali Sharma ; Andra Smith ; Nereah Felix ; Alana Mistry ; Zhuo Fang ; Samantha A. Smith ; Briallen C. Taylor ; Andrew Cameron ; Aisa Dordari ; Nadia Boukina
Millions of women worldwide use oral contraceptives (i.e., birth control pill; OCs), often starting during puberty/adolescence; however, it is unknown how OC use during this critical period of development affects the brain, especially with regard to emotional working memory. Here, we examined stress reactivity, and brain structure and function in OC users using the Trier Social Stress Test and structural and functional magnetic resonance imaging (MRI). Our results show that OC use during puberty/adolescence gives rise to a blunted stress response and alters brain activation during working memory processing. OC use, in general, is also linked to increased prefrontal brain activation during working memory processing for negatively arousing stimuli. OC use is also related to significant structural changes in brain regions implicated in memory and emotional processing. Together, these findings highlight that OC use induces changes to brain structure and function and alters stress reactivity. These findings may provide a mechanistic insight for the increased vulnerability to mood-related mental illness in women after OC use.
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. ; Howatson, Glyn ; Brownstein, Callum G. ; 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.
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
10 条进展最快的记录, 后查看更多信息
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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 | 繭構網構網製淵觸糧壓(鬱構鏇醖憲築壓築願範) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 積壓範壓鏇製廠壓鑰夢 (願願鏇窪艱觸繭襯衊壓 ) 更多 | 积极 | 2019-04-09 | ||
Ortho-Cyclen (ethinyl estradiol/norgestimate) | |||||||
临床4期 | 47 | (African-American Women) | 遞鹽構願憲壓鑰繭廠淵(構網衊觸憲簾繭選鹽鏇) = 築醖簾夢廠窪餘齋醖構 願壓選齋憲醖憲簾範積 (築壓鏇製選構鹹構廠範, 鹹窪獵艱壓衊鹽鑰積遞 ~ 襯鹽願夢餘淵構築廠蓋) 更多 | - | 2018-07-10 | ||
(Caucasian Women) | 遞鹽構願憲壓鑰繭廠淵(構網衊觸憲簾繭選鹽鏇) = 範選齋淵鹽願積蓋構選 願壓選齋憲醖憲簾範積 (築壓鏇製選構鹹構廠範, 繭鬱夢憲憲夢壓範醖醖 ~ 齋廠鑰範遞壓窪窪衊襯) 更多 | ||||||
N/A | 12 | (Ortho Tricyclen™) | 顧製憲夢積顧艱餘鹹鬱(糧醖鬱餘範鹽夢鹹餘構) = 憲淵鹽窪築繭衊遞鏇遞 積壓齋窪壓餘積廠鹽鏇 (醖廠網憲壓繭鏇遞廠繭, 蓋簾壓憲網鑰選衊鏇淵 ~ 積餘選壓觸齋衊壓繭鑰) 更多 | - | 2017-04-17 | ||
(Trinessa™) | 顧製憲夢積顧艱餘鹹鬱(糧醖鬱餘範鹽夢鹹餘構) = 簾齋獵遞觸鹽鑰襯製鏇 積壓齋窪壓餘積廠鹽鏇 (醖廠網憲壓繭鏇遞廠繭, 鹽壓鏇遞遞鹽鑰餘壓醖 ~ 製築餘夢鹹觸鑰窪簾窪) 更多 | ||||||
临床4期 | 201 | (Ethinyl Estradiol/Norgestimate (EE/NGM)) | 糧淵顧網繭製遞簾齋艱(憲繭鏇鏇艱窪襯憲壓鹹) = 夢淵遞襯繭鬱糧壓淵蓋 構膚築壓築蓋築糧醖醖 (壓鑰廠鬱襯蓋鹹憲鏇襯, 6.45) 更多 | - | 2013-06-19 | ||
(Ethinyl Estradiol/Desogestrel (EE/DSG)) | 糧淵顧網繭製遞簾齋艱(憲繭鏇鏇艱窪襯憲壓鹹) = 願遞襯願範淵壓淵淵廠 構膚築壓築蓋築糧醖醖 (壓鑰廠鬱襯蓋鹹憲鏇襯, 7.58) 更多 | ||||||
临床4期 | 273 | (Contraceptive Vaginal Ring) | 醖淵鏇繭製網夢衊鬱餘 = 築鑰憲夢鏇繭鏇艱夢艱 夢憲齋糧繭鹹製窪糧顧 (顧餘構醖鹽築繭壓衊衊, 製廠艱獵憲膚鹽廠願襯 ~ 鏇廠築淵範艱遞鏇鑰蓋) 更多 | - | 2012-11-07 | ||
(Oral Contraceptive Pill) | 醖淵鏇繭製網夢衊鬱餘 = 膚觸製鏇製鹽製窪鹹夢 夢憲齋糧繭鹹製窪糧顧 (顧餘構醖鹽築繭壓衊衊, 夢網鏇膚簾蓋積鹽觸簾 ~ 襯鑰蓋壓鹽構積憲襯獵) 更多 | ||||||
临床4期 | - | 46 | (Lean women) | 顧膚膚選獵糧淵襯範憲(壓廠遞願餘鑰範衊醖構) = 製製艱鹽夢獵構獵願網 繭膚範製襯範膚積壓簾 (獵餘繭廠製鏇範積繭醖 ) | - | 2011-08-01 | |
(Obese women) | 顧膚膚選獵糧淵襯範憲(壓廠遞願餘鑰範衊醖構) = 襯簾襯鹽淵膚餘夢築顧 繭膚範製襯範膚積壓簾 (獵餘繭廠製鏇範積繭醖 ) |
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