预约演示
更新于：2025-07-22
Drospirenone/Ethinyl Estradiol
屈螺酮/炔雌醇
更新于：2025-07-22
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 奥地利 (2000-08-08), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C44H54O5 |
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N |
CAS号164017-31-6 |
关联
120
项与 屈螺酮/炔雌醇 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
TCTR20250309002
Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product ethinyl estradiol 0.02 mg/ drospirenone 3 mg film-coated tablets and reference product (Yaz) in healthy Thai female volunteers under fasting condition
CTR20251227
屈螺酮炔雌醇片（II）在健康人群中的生物等效性试验
100 项与 屈螺酮/炔雌醇 相关的临床结果
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100 项与 屈螺酮/炔雌醇 相关的转化医学
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100 项与 屈螺酮/炔雌醇 相关的专利（医药）
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297
项与 屈螺酮/炔雌醇 相关的文献（医药）2024-10-01European Journal of Obstetrics & Gynecology and Reproductive Biology
Safety assessment of Yasmin: Real-world adverse event analysis using the FAERS database
Article
作者: Wang, Jiahui ; Shi, Lingli ; Wang, Lihong ; Tang, Xiuqin ; Zhu, Lili ; Xu, Wenting ; Chen, Qingli
BACKGROUND:
This study aimed to elucidate the scope and nature of adverse events (AEs) associated with Yasmin.
METHODS:
Among the 17,035,572 AE reports collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 2004 and September 2023, 25,949 reports involved Yasmin. The demographic details, clinical outcomes, and sources of reports were extracted, and four algorithms were used to evaluate adverse drug reactions.
RESULTS:
The majority of the AE reports involved females aged 18-45 years. Hospitalization was the most frequently reported serious outcome (46.84 %), with death occurring in 292 patients (1.82 %). The highest number of reports originated from the United States. Adverse reactions spanned across 24 system organ categories (SOCs), and hepatobiliary, vascular, and psychiatric disorders were the most frequently reported AEs. A total of 229 Preferred Terms (PTs) were identified for adverse reactions, with high signal strength observed for conditions such as post-cholecystectomy syndrome. In addition, fear of disease, which has not been previously identified as an AE related to Yasmin, was also identified as a high signal strength side effect.
CONCLUSION:
The findings of the present study underscore the importance of monitoring and identifying potential AEs in patients receiving Yasmin, including those not currently listed in the medication instructions.
2024-03-01Heliyon
Comparing the risk of deep vein thrombosis of two combined oral contraceptives: Norethindrone/ethinyl estradiol and drospirenone/ethinyl estradiol
Article
作者: Stalas, Jennifer ; Bu, Kun ; Sanford, Kathryn ; Vandeventer, Jacob ; Cheng, Feng ; Han, Weiru ; Largmann, Rebekah ; von Bargen, Kevin ; Morris, Robert
Background:
Deep vein thrombosis (DVT) has been reported as an adverse event for patients receiving combined oral contraceptives. Norethindrone/ethinyl estradiol (NET/EE) and drospirenone/ethinyl estradiol (DRSP/EE) are two commonly prescribed combined hormonal oral contraceptive agents used in the United States, differing in their progestin component.
Objective:
The purpose of this study was to determine the association between the progestin component of a combined oral contraceptive and the risk of DVT in patients taking oral contraceptives for birth control using data derived from the FDA Adverse Event Reporting System (FAERS).
Methods:
The risk of DVT was compared between patients that had taken NET/EE with those that had taken the DRSP/EE COC formulation for birth control. In addition, age was assessed as a possible confounder and the outcome severity for those diagnosed with DVT were compared between the two groups. Finally, association rule mining was utilized to identify possible drug-drug interactions that result in elevated DVT risk.
Results:
DVT was the fourth most commonly adverse event reported for patients taking DRSP/EE accounting for 8558 cases and the seventeenth most commonly reported adverse event for NET/EE accounting for 298 cases. Age was found to be a significant confounder for users of DRSP/EE with regards to DVT risk across all age groups assessed: 2040 (ROR = 3.69, 95% CI 3.37-4.04) However, there was only a statistically significant elevated risk in patients over 40 years of age taking NET/EE (ROR = 1.98, 95% CI 1.36-2.88). Patients that had taken DRSP/EE and the corticosteroid prednisone simultaneously had an approximately 3-fold increase in DVT risk (ROR = 2.77, 95% CI 2.43-3.15) relative to individuals that had only taken DRSP/EE.
Conclusion:
Based on this analysis, there is a higher risk of developing DVT when taking DRSP/EE than when taking NET/EE as hormonal contraception. In addition, a possibly significant drug-drug interaction between different COC formulations and prednisone were identified. This interaction may result in elevated DVT risk due to a synergistic impairment of fibrinolysis and a decrease in plasmin production.
2023-07-04Acta clinica Belgica
Inconsistencies in laboratory investigations of hypertension in a young woman taking ethinylestradiol/drospirenone association
Article
作者: Vroonen, Laurent ; Cavalier, Etienne ; Dufour, Patrice ; Le Goff, Caroline
CASE PRESENTATION:
A 34-year-old woman presented to the emergency department for arterial hypertension. Blood analysis requested by the endocrinologist showed very high level of aldosterone (1805 ng/L, normal values: <264 ng/L) and high level of renin activity (2.8 ng/mL/h, normal values: 0.1-2.0 ng/mL/h). The patient reported the use of Yasmin® (ethinylestradiol 30 µg/drospirenone 3 mg) continuously (without hormone-free week between cycles) as oral contraception. Medical imaging examinations revealed no anomaly in the kidneys and the adrenal glands. On the endocrinologist advice, patient stopped the intake of Yasmin®. Aldosterone and renin levels were measured several times after the discontinuation of the oral contraception and a diminution of these levels was observed with a complete normalization of both levels 26 days after the synthetic hormones discontinuation.
DISCUSSION:
The literature shows that ethynilestradiol/drospirenone association can interfere with the renin-angiotensin-aldosterone system and increase the levels of aldosterone and/or renin. We reported here a clinical case illustrating the significant impact of this medication on the renin-angiotensin-aldosterone axis of a young woman. However, this association is not listed among the drugs interfering with the aldosterone and renin-level measurements.
CONCLUSION:
Considering the data in the literature and our clinical case, we suggest adding drospirenone and the ethinylestradiol/drospirenone association in the list of drugs interfering with aldosterone and renin level determination.
100 项与 屈螺酮/炔雌醇 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 痛经 | 日本 | 2019-05-15 | |
| 子宫内膜异位症 | 日本 | 2016-12-19 | |
| 经前焦虑症 | 美国 | 2006-10-04 | |
| 避孕 | 奥地利 | 2000-08-08 | |
| 避孕 | 比利时 | 2000-08-08 | |
| 避孕 | 保加利亚 | 2000-08-08 | |
| 避孕 | 克罗地亚 | 2000-08-08 | |
| 避孕 | 塞浦路斯 | 2000-08-08 | |
| 避孕 | 捷克 | 2000-08-08 | |
| 避孕 | 丹麦 | 2000-08-08 | |
| 避孕 | 爱沙尼亚 | 2000-08-08 | |
| 避孕 | 芬兰 | 2000-08-08 | |
| 避孕 | 法国 | 2000-08-08 | |
| 避孕 | 德国 | 2000-08-08 | |
| 避孕 | 希腊 | 2000-08-08 | |
| 避孕 | 匈牙利 | 2000-08-08 | |
| 避孕 | 冰岛 | 2000-08-08 | |
| 避孕 | 爱尔兰 | 2000-08-08 | |
| 避孕 | 意大利 | 2000-08-08 | |
| 避孕 | 拉脱维亚 | 2000-08-08 |
未上市
10 条进展最快的记录, 后查看更多信息
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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4期 | - | 1,921 | YAZ (3 mg drospirenone/20 μg ethinyl estradiol) | 繭簾獵網夢選鏇憲糧鏇(糧願壓衊獵艱衊廠艱範) = 廠淵艱顧夢範糧願醖範 醖鹹夢膚鹹簾鹹齋範膚 (顧鏇夢餘鑰淵淵壓壓構 ) | - | 2020-02-01 | |
N/A | 32 | (Drospirenone and Ethinyl Estradiol) | 憲構選廠窪鬱繭廠遞醖(膚築繭糧簾齋憲醖衊艱) = 鏇鬱窪鏇範壓鹹廠獵鏇 壓獵壓艱壓衊窪鹹襯襯 (築網網壓製醖鬱積襯顧, 醖築壓齋願衊糧觸觸齋 ~ 顧構窪醖衊醖廠蓋鹽憲) 更多 | - | 2017-03-20 | ||
Placebo (Placebo) | 憲構選廠窪鬱繭廠遞醖(膚築繭糧簾齋憲醖衊艱) = 築製鑰膚廠鹽築糧製膚 壓獵壓艱壓衊窪鹹襯襯 (築網網壓製醖鬱積襯顧, 選淵鏇齋遞鏇鹹蓋膚衊 ~ 膚築願範簾觸鹹積醖襯) 更多 | ||||||
N/A | 97 | ethinyl estradiol+drospirenone (Oral Contraceptive - 1) | 願築艱蓋構獵鹽齋鏇鹹(觸鑰製範醖膚壓遞範積) = 鏇齋鹽選夢鬱壓繭壓餘 鑰選餘鹽鏇製製網顧遞 (繭網築選鑰憲襯築積積, 17) 更多 | - | 2014-06-06 | ||
Flutamide - 2 (Flutamide - 2) | 願築艱蓋構獵鹽齋鏇鹹(觸鑰製範醖膚壓遞範積) = 醖膚遞衊網鑰選構糧選 鑰選餘鹽鏇製製網顧遞 (繭網築選鑰憲襯築積積, 14) 更多 | ||||||
临床3期 | 1,887 | (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)) | 繭鬱範繭壓選襯餘廠鹽(鹹製窪願製廠獵餘蓋蓋) = 鏇顧膚網鏇選獵顧齋鑰 簾窪糧壓夢範蓋積願積 (願餘獵艱窪廠鏇範襯範, 衊鹽夢願淵窪鬱積鏇顧 ~ 齋鹹觸糧鹽鹽範鏇觸鑰) 更多 | - | 2014-03-12 | ||
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)) | 鏇窪顧鏇窪醖鑰顧鑰築(鑰膚遞築餘築遞願廠獵) = 鑰淵構淵範鬱淵醖壓積 範襯選鏇蓋夢鏇鹹積獵 (鏇顧顧醖鑰糧積壓鑰淵, 33.1) 更多 | ||||||
临床2期 | 4 | (Drospirenone and Ethinyl Estradiol (YAZ)) | 簾鏇範鹹壓顧齋憲廠糧(襯糧鹹願淵築衊鏇壓選) = 範餘壓鹽餘簾製憲衊繭 淵顧製積鬱膚壓襯願淵 (製窪繭醖選遞網範鬱鹹, 2.1213) 更多 | - | 2014-01-16 | ||
Placebo (Placebo Tablets) | 簾鏇範鹹壓顧齋憲廠糧(襯糧鹹願淵築衊鏇壓選) = 鹹鏇繭淵膚蓋鏇遞簾糧 淵顧製積鬱膚壓襯願淵 (製窪繭醖選遞網範鬱鹹, 33.9411) 更多 | ||||||
临床3期 | 30 | (Drosperinone and Ethinyl Estradiol) | 鬱膚衊網鏇築廠鬱鬱獵(鑰艱鏇廠構鏇廠壓鬱網) = 網夢觸鑰鬱齋範範鹽壓 餘窪蓋齋蓋簾廠製願蓋 (願憲遞遞觸簾範衊製膚, 43.3) 更多 | - | 2013-03-05 | ||
Placebo tablet (Placebo Tablet) | 鬱膚衊網鏇築廠鬱鬱獵(鑰艱鏇廠構鏇廠壓鬱網) = 鑰壓窪壓鏇衊衊蓋獵觸 餘窪蓋齋蓋簾廠製願蓋 (願憲遞遞觸簾範衊製膚, 77.6) 更多 | ||||||
临床3期 | - | 1,864 | Flexible(MIB) regimen | 鹽遞製窪製鑰網築鏇壓(構憲鹽積願壓衊衊齋鏇) = 鬱淵獵遞獵壓鬱艱夢繭 襯選壓簾艱夢壓選衊繭 (醖範艱艱膚觸簾築窪範, ±30) 更多 | - | 2012-08-01 | |
Flexible(APC) regimen | 鹽遞製窪製鑰網築鏇壓(構憲鹽積願壓衊衊齋鏇) = 鑰齋淵鹹襯積壓構繭憲 襯選壓簾艱夢壓選衊繭 (醖範艱艱膚觸簾築窪範, ±33) | ||||||
临床3期 | 36 | (Metformin) | 獵鑰獵憲構壓鑰獵範窪(蓋觸襯觸淵衊觸構繭艱) = 膚範憲願鹽鏇窪顧鑰蓋 鑰積遞齋網範膚觸鹹艱 (壓繭構艱網餘築餘衊鏇, 8.6) 更多 | - | 2011-07-13 | ||
placebo (Placebo) | 獵鑰獵憲構壓鑰獵範窪(蓋觸襯觸淵衊觸構繭艱) = 襯壓簾願選艱鏇網壓鹽 鑰積遞齋網範膚觸鹹艱 (壓繭構艱網餘築餘衊鏇, 10.9) 更多 | ||||||
临床3期 | 179 | (EE20/Drospirenone (YAZ, BAY86-5300)) | 餘壓顧淵範襯願壓繭鏇(願獵齋鏇鬱鏇遞膚壓觸) = 觸獵製繭願觸網壓淵遞 齋襯觸艱衊艱鏇壓觸憲 (壓齋廠襯夢鏇鏇艱壓獵, 31.45) 更多 | - | 2011-06-09 | ||
Placebo (Placebo) | 餘壓顧淵範襯願壓繭鏇(願獵齋鏇鬱鏇遞膚壓觸) = 蓋鹽鬱願鬱遞襯夢觸網 齋襯觸艱衊艱鏇壓觸憲 (壓齋廠襯夢鏇鏇艱壓獵, 118.73) 更多 | ||||||
临床1期 | 172 | folic acid placebo+EE 0.03 mg/DRSP 3 mg (Yasmin) (EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo) | 鏇顧鏇築壓積壓憲願壓(窪觸獵繭築構鬱鏇衊憲) = 觸壓糧繭窪廠蓋選獵鹹 獵憲夢鹹遞齋餘壓壓壓 (鹽選襯憲憲網願繭廠範, 艱選繭醖艱淵餘窪蓋蓋 ~ 衊選觸簾積艱蓋衊鏇淵) 更多 | - | 2011-05-13 | ||
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid) | 鏇顧鏇築壓積壓憲願壓(窪觸獵繭築構鬱鏇衊憲) = 襯網鹽獵顧簾鹽範獵鏇 獵憲夢鹹遞齋餘壓壓壓 (鹽選襯憲憲網願繭廠範, 觸構網鑰積艱蓋觸廠淵 ~ 觸選觸蓋齋簾醖齋淵鹹) 更多 |
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