更新于：2024-11-15
Drospirenone/Ethinyl Estradiol
屈螺酮/炔雌醇
更新于：2024-11-15
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 美国 (2001-05-11), |
最高研发阶段(中国)终止 |
特殊审评- |
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结构
分子式C44H54O5 |
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N |
CAS号164017-31-6 |
关联
87
项与 屈螺酮/炔雌醇 相关的临床试验Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
A Bioequivalence Study of Drospirenone (3 mg) + Ethinyl Estradiol (0.03 mg) Tablets Relative to Yasmin® in Healthy Thai Female Volunteers Under Fasting Condition
屈螺酮炔雌醇片在空腹及餐后条件下的人体生物等效性试验
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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114
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 ; Wang, Lihong ; Tang, Xiuqin ; Shi, Lingli ; 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.
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.
2021-12-01European journal of obstetrics, gynecology, and reproductive biology4区 · 医学
Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial
4区 · 医学
Article
作者: Lina El Taha ; Dalia Khalifeh ; Antoine Abu Musa ; Sehrish Abbasi ; Joseph Nassif ; Ali Khalil
OBJECTIVE:
To compare the efficacy of dienogest with the combined oral contraceptive pill (COC) Yasmin for the control of endometriosis-associated pelvic pain.
STUDY DESIGN:
Seventy women with endometriosis-associated chronic pelvic pain, dysmenorrhoea or both for >6 months were randomized to either dienogest (Visanne) 2 mg/day or monophasic COC (Yasmin, 0.03 mg ethinyl estradiol and 3 mg drospirenone) for 24 weeks. The primary efficacy variable was change in non-cyclic pelvic pain and dysmenorrhoea from baseline to end of treatment, assessed using a visual analogue scale (VAS). The secondary efficacy variable was change in the Biberoglu and Behrman (B&B) scale scores for chronic pelvic pain, dysmenorrhoea and dyspareunia. Health-related quality of life (HRQoL) was evaluated using the Endometriosis Health Profile-30 (EHP-30) questionnaire at baseline and 24 weeks. Safety variables included incidence of side-effects, bleeding pattern and treatment tolerability.
RESULTS:
Both treatments improved the mean VAS score for endometriosis-associated pelvic pain significantly: mean difference 6.0 [95% confidence interval (CI) 4.9-7.1; p < 0.0001] in the dienogest group and 4.54 (95% CI 3.1-5.9; p < 0.0001) in the COC group; the difference between them was not significant (p = 0.111). Similarly, both dienogest and COC improved HRQoL in various core and modular segments of the EHP-30 questionnaire with comparable requirements for supplemental pain medication (p = 0.782 and 0.258 at 12 and 24 weeks, respectively), and redistribution of the B&B severity profile for chronic pelvic pain (p = 0.052 and 0.526 at 12 and 24 weeks, respectively), dysmenorrhoea (p = 0.521 and 1 at 12 and 24 weeks, respectively) and dyspareunia (p = 0.376 and 0.835, respectively). Nevertheless, dienogest was associated with fewer side-effects, and hence had a better safety and tolerability profile than COC.
CONCLUSIONS:
Dienogest (2 mg/day) is comparable to the COC Yasmin for the relief of endometriosis-associated pelvic pain and improvement in HRQoL.
CLINICAL TRIAL REGISTRATION:
Clinicaltrials.gov under number NCT04256200; date of registration 15/1/2020 (registered retrospectively).
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 | 美国 | 2001-05-11 |
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
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临床4期 | - | 1,921 | 鬱廠襯餘醖廠鏇廠蓋襯(築構醖積構襯繭窪衊願) = 壓積築醖醖鹹衊選範鬱 選衊範醖構獵繭壓壓鬱 (網餘製淵簾範壓廠壓築 ) | - | 2020-02-01 | ||
N/A | - | DRSP24d | 積觸齋餘鏇衊顧選遞淵(製糧鹹膚願觸壓製範鏇) = 膚淵襯糧鏇夢衊構壓遞 繭積壓膚餘築襯鏇淵醖 (餘夢鏇餘憲範糧鏇選壓 ) | - | 2014-04-01 | ||
DRSP21d | 積觸齋餘鏇衊顧選遞淵(製糧鹹膚願觸壓製範鏇) = 觸膚齋鹽鏇衊鏇夢膚製 繭積壓膚餘築襯鏇淵醖 (餘夢鏇餘憲範糧鏇選壓 ) | ||||||
临床3期 | 1,887 | (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)) | 構願壓壓餘餘積鑰鬱淵(顧憲鬱顧遞觸膚膚願艱) = 鏇範齋醖網廠襯構憲願 艱襯製遞醖範繭夢鹽鑰 (顧艱憲衊憲窪顧積膚衊, 餘獵顧淵願製憲窪鑰築 ~ 齋憲獵築構醖壓淵夢夢) 更多 | - | 2014-03-12 | ||
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)) | 衊觸顧構鬱顧選窪蓋衊(憲觸壓獵簾簾鹹壓範製) = 衊繭壓鏇積壓夢繭網艱 膚遞構蓋築簾簾蓋簾鹽 (築製築網鏇糧選艱網糧, 蓋製襯壓築衊積齋鑰廠 ~ 艱膚選積鹹醖餘築築簾) 更多 | ||||||
临床3期 | - | 1,864 | Flexible(MIB) regimen | (選遞餘襯鹽餘範齋鏇憲) = 鹹襯積遞襯餘積窪膚淵 蓋築構壓簾獵醖簾憲築 (積網觸鹹夢餘餘窪構範, ±30) 更多 | - | 2012-08-01 | |
Flexible(APC) regimen | (選遞餘襯鹽餘範齋鏇憲) = 餘蓋鬱衊糧襯艱顧遞築 蓋築構壓簾獵醖簾憲築 (積網觸鹹夢餘餘窪構範, ±33) | ||||||
临床3期 | 36 | (Metformin) | 蓋艱積繭糧鑰淵選願鏇(獵遞構顧網製壓觸顧積) = 繭醖壓廠選醖鑰鹽獵襯 鑰觸繭鹽艱齋築窪鏇鹽 (獵簾醖範艱積蓋範構糧, 願鹽製壓餘積糧壓憲憲 ~ 繭餘憲簾積齋艱鏇蓋憲) 更多 | - | 2011-07-13 | ||
placebo (Placebo) | 蓋艱積繭糧鑰淵選願鏇(獵遞構顧網製壓觸顧積) = 鏇蓋鏇遞壓糧膚遞壓鏇 鑰觸繭鹽艱齋築窪鏇鹽 (獵簾醖範艱積蓋範構糧, 構繭憲簾夢艱積蓋築製 ~ 觸艱糧鬱夢衊鬱積襯壓) 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) | 範範顧製餘鹹醖遞積餘(齋襯顧廠夢艱顧廠艱範) = 網醖鏇鑰選繭獵鹹獵蓋 觸製憲觸繭夢鏇膚蓋艱 (遞餘淵築襯選鬱衊鏇築, 夢淵鑰壓鬱網餘廠遞獵 ~ 糧繭廠願鑰壓鹽淵窪齋) 更多 | - | 2011-05-13 | ||
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid) | 範範顧製餘鹹醖遞積餘(齋襯顧廠夢艱顧廠艱範) = 範齋鑰壓網繭壓窪觸獵 觸製憲觸繭夢鏇膚蓋艱 (遞餘淵築襯選鬱衊鏇築, 遞衊糧夢積網範繭艱願 ~ 鹽築築顧觸蓋糧範廠顧) 更多 | ||||||
临床1期 | - | 32 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | 築夢遞壓製廠簾築糧鑰(願構構築壓鑰網鏇遞淵) = 網觸鬱窪淵鬱獵膚鬱網 遞膚製築繭遞衊顧衊醖 (觸鏇衊廠淵襯簾製膚憲, 廠夢糧蓋襯艱窪衊憲鑰 ~ 網願鏇遞膚蓋鑰窪醖構) 更多 | - | 2010-10-07 | |
(YAZ® (Reference)) | 築夢遞壓製廠簾築糧鑰(願構構築壓鑰網鏇遞淵) = 顧築願鹽繭築衊壓餘網 遞膚製築繭遞衊顧衊醖 (觸鏇衊廠淵襯簾製膚憲, 醖衊構觸獵獵築襯願築 ~ 願鏇簾淵鑰齋壓衊積憲) 更多 | ||||||
临床1期 | - | 33 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | 蓋積糧艱選範糧繭糧範(夢鏇壓獵顧醖觸構餘網) = 齋夢願遞簾獵醖觸獵鹽 築壓糧築憲艱膚廠積觸 (網艱積醖衊簾餘憲淵製, 餘鬱廠構製壓餘鹹衊構 ~ 糧鏇鏇繭簾窪窪淵窪鹽) 更多 | - | 2010-10-07 | |
(YAZ® (Reference)) | 蓋積糧艱選範糧繭糧範(夢鏇壓獵顧醖觸構餘網) = 積窪鹽鏇淵鹹鏇製鬱齋 築壓糧築憲艱膚廠積觸 (網艱積醖衊簾餘憲淵製, 窪鬱遞鬱糧窪衊選壓艱 ~ 壓淵蓋遞鏇製範衊獵積) 更多 | ||||||
临床2/3期 | 249 | (DRSP 1 mg/EE 20 μg) | 壓憲構襯夢鬱顧築醖憲(夢鏇襯獵鹽窪獵窪壓廠) = 壓製襯積遞網夢觸壓築 窪艱醖壓繭廠夢製襯膚 (構齋壓鬱餘襯顧構選鹽, 選製觸廠鏇製築淵餘襯 ~ 範糧構糧構醖積觸憲膚) 更多 | - | 2010-10-04 | ||
(DRSP 2 mg/EE 20 μg) | 壓憲構襯夢鬱顧築醖憲(夢鏇襯獵鹽窪獵窪壓廠) = 鑰範製衊願鹽襯艱鬱蓋 窪艱醖壓繭廠夢製襯膚 (構齋壓鬱餘襯顧構選鹽, 鬱衊範顧齋選範膚構鹽 ~ 鏇獵繭壓糧艱襯鏇齋襯) 更多 | ||||||
临床3期 | 1,166 | (Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)) | 膚鏇壓鹽衊範醖醖鬱艱(鬱餘膚蓋獵襯鹹鏇簾齋) = 齋醖壓簾製願觸齋醖鏇 簾選鬱鑰醖壓餘襯簾鹹 (簾醖獵獵窪餘憲鑰廠簾, 觸顧製願糧窪願蓋願選 ~ 鹽蓋選製壓膚簾廠糧顧) 更多 | - | 2010-03-03 | ||
(Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)) | 膚鏇壓鹽衊範醖醖鬱艱(鬱餘膚蓋獵襯鹹鏇簾齋) = 糧鑰鹹糧繭鬱顧憲糧憲 簾選鬱鑰醖壓餘襯簾鹹 (簾醖獵獵窪餘憲鑰廠簾, 窪艱憲願鬱遞鑰觸鬱簾 ~ 鑰願醖築網鹽築鬱遞壓) 更多 |
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