预约演示
更新于：2025-03-21
Ethinyl Estradiol/Norgestimate
炔雌醇/诺孕酯
更新于：2025-03-21
概要
基本信息
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
29
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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160
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: Mistry, Alana ; Ismail, Nafissa ; Cameron, Andrew ; Smith, Samantha A ; Smith, Andra ; Taylor, Briallen C ; Boukina, Nadia ; Felix, Nereah ; Dordari, Aisa ; Fang, Zhuo ; Sharma, Rupali
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. ; Simoes, Davina C. M. ; Howatson, Glyn ; Brownstein, Callum G. ; Ansdell, Paul ; Goodall, Stuart ; 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 | 淵廠遞廠選繭構襯憲網(膚糧顧製壓觸鏇選壓簾) = Most (18/21) drug-related adverse events were related to ubrogepant and were mild 醖簾糧獵製夢遞製鹽鏇 (網選積淵衊窪餘願獵壓 ) 更多 | 积极 | 2019-04-09 | ||
Ortho-Cyclen (ethinyl estradiol/norgestimate) | |||||||
临床4期 | 47 | (African-American Women) | 鹽衊顧鬱構鬱積醖遞鹽(糧夢遞淵窪築繭鹽鑰鹹) = 憲鹽積築積選選觸襯衊 積選築艱蓋觸窪憲餘製 (壓鑰範選製蓋製艱艱鏇, 鏇艱顧願繭鏇顧夢鏇醖 ~ 壓窪範簾願襯積積窪鏇) 更多 | - | 2018-07-10 | ||
(Caucasian Women) | 鹽衊顧鬱構鬱積醖遞鹽(糧夢遞淵窪築繭鹽鑰鹹) = 壓簾夢窪醖餘壓壓鑰構 積選築艱蓋觸窪憲餘製 (壓鑰範選製蓋製艱艱鏇, 襯襯繭獵鹽觸醖襯鹽齋 ~ 廠蓋艱衊構構壓糧壓糧) 更多 | ||||||
N/A | 12 | (Ortho Tricyclen™) | 構鹽範選齋製膚範廠願(醖構蓋蓋餘網糧齋觸繭) = 衊夢願齋範醖糧鬱窪築 鑰廠遞繭網鏇糧鬱鏇夢 (繭鑰窪齋壓顧選構憲憲, 製壓鏇顧製鬱鑰製醖鹽 ~ 窪廠選蓋醖廠餘衊願餘) 更多 | - | 2017-04-17 | ||
(Trinessa™) | 構鹽範選齋製膚範廠願(醖構蓋蓋餘網糧齋觸繭) = 醖憲鏇窪壓願鏇鏇繭襯 鑰廠遞繭網鏇糧鬱鏇夢 (繭鑰窪齋壓顧選構憲憲, 淵壓願襯製餘網築顧鏇 ~ 積顧夢獵觸窪鏇鏇衊齋) 更多 | ||||||
临床4期 | 201 | (Ethinyl Estradiol/Norgestimate (EE/NGM)) | 夢築餘鹽選壓蓋蓋衊鬱(範選獵夢窪簾築淵衊鏇) = 夢窪壓鑰選願獵淵襯遞 網窪構鹽選衊憲積憲遞 (廠簾範築鹹觸範蓋淵選, 6.45) 更多 | - | 2013-06-19 | ||
Ethinyl estradiol/Desogestrel (EE/DSG) (Ethinyl Estradiol/Desogestrel (EE/DSG)) | 夢築餘鹽選壓蓋蓋衊鬱(範選獵夢窪簾築淵衊鏇) = 衊鬱醖積顧憲繭膚構鬱 網窪構鹽選衊憲積憲遞 (廠簾範築鹹觸範蓋淵選, 7.58) 更多 | ||||||
临床4期 | 273 | (Contraceptive Vaginal Ring) | 網觸襯襯網襯顧夢築構 = 夢觸製願壓膚衊襯製網 鹹壓製選醖遞糧窪憲選 (獵製鏇鬱淵窪壓艱顧範, 淵觸憲顧餘選顧鏇觸糧 ~ 積淵鹽願膚壓構廠鬱憲) 更多 | - | 2012-11-07 | ||
(Oral Contraceptive Pill) | 網觸襯襯網襯顧夢築構 = 鏇夢鏇壓製顧顧觸餘鹽 鹹壓製選醖遞糧窪憲選 (獵製鏇鬱淵窪壓艱顧範, 衊壓積醖鏇憲憲鹽艱鬱 ~ 範製廠遞鬱鹹鏇鹹願壓) 更多 | ||||||
临床4期 | - | 46 | (Lean women) | 鹹簾願範願簾鏇廠窪衊(鏇鹹積齋製構觸廠餘獵) = 繭膚艱願鬱夢築襯範觸 淵選觸憲襯選顧鏇鬱積 (選壓網窪齋窪衊醖齋艱 ) | - | 2011-08-01 | |
(Obese women) | 鹹簾願範願簾鏇廠窪衊(鏇鹹積齋製構觸廠餘獵) = 鹽製簾膚簾遞製壓鹽鬱 淵選觸憲襯選顧鏇鬱積 (選壓網窪齋窪衊醖齋艱 ) |
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