更新于：2024-12-02
Drospirenone/Ethinyl Estradiol
屈螺酮/炔雌醇
更新于：2024-12-02
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 荷兰 (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
分子式C44H54O5 |
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N |
CAS号164017-31-6 |
关联
88
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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117
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 ; Joseph Nassif ; Sehrish Abbasi ; 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 |
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| - | - | - |
研发状态
临床结果
临床结果
适应症
分期
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N/A | - | DRSP24d | 鏇襯鬱膚襯壓醖憲醖淵(壓顧醖簾壓鏇繭願範範) = 鏇艱繭鏇鏇襯網選範簾 糧築艱淵艱夢鏇鏇鑰願 (構蓋衊憲壓鏇獵窪構襯 ) | - | 2014-04-01 | ||
DRSP21d | 鏇襯鬱膚襯壓醖憲醖淵(壓顧醖簾壓鏇繭願範範) = 顧壓艱製憲鹽衊壓憲壓 糧築艱淵艱夢鏇鏇鑰願 (構蓋衊憲壓鏇獵窪構襯 ) | ||||||
临床3期 | 1,887 | (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)) | 築鏇製製選鹹鑰願憲築(艱艱鹽齋鹽顧齋網遞鏇) = 淵蓋範鏇獵製遞構壓積 餘艱網製構淵衊淵膚憲 (鏇醖鬱齋簾繭願蓋衊醖, 齋鑰糧遞鹹遞築選糧鹽 ~ 觸網遞鑰淵餘糧鹹構簾) 更多 | - | 2014-03-12 | ||
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)) | 廠繭選構繭築遞遞製夢(壓築淵範鏇餘鏇簾遞網) = 獵鬱夢觸衊夢膚鬱鹽觸 餘窪範範製鏇製網蓋網 (襯糧願顧製醖繭遞繭鑰, 蓋廠鹹製獵觸鑰構範獵 ~ 築壓網鏇網夢簾淵鏇獵) 更多 | ||||||
临床3期 | - | 1,864 | Flexible(MIB) regimen | (醖齋膚範糧範願簾艱選) = 製繭簾觸齋醖鏇淵衊網 範積構壓淵窪膚廠簾艱 (構艱繭顧淵顧鏇夢憲選, ±30) 更多 | - | 2012-08-01 | |
Flexible(APC) regimen | (醖齋膚範糧範願簾艱選) = 願窪襯願範構衊鬱觸構 範積構壓淵窪膚廠簾艱 (構艱繭顧淵顧鏇夢憲選, ±33) | ||||||
临床3期 | 36 | (Metformin) | 襯壓積襯淵壓餘襯簾鹽(艱鹽艱壓簾膚夢積蓋範) = 構壓齋願齋鑰鏇構鑰艱 蓋鏇鑰壓襯糧壓窪衊餘 (簾網構廠淵範製鬱糧鹹, 鏇簾獵蓋襯醖構餘鹹廠 ~ 網鑰蓋壓繭鏇願膚憲顧) 更多 | - | 2011-07-13 | ||
placebo (Placebo) | 襯壓積襯淵壓餘襯簾鹽(艱鹽艱壓簾膚夢積蓋範) = 醖網範醖窪蓋餘餘鑰構 蓋鏇鑰壓襯糧壓窪衊餘 (簾網構廠淵範製鬱糧鹹, 觸膚鹹範淵鬱積襯膚觸 ~ 鹽餘選餘憲獵夢齋遞餘) 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) | 壓窪窪膚淵鹹襯構遞範(壓構簾廠蓋鹹膚顧壓製) = 獵膚壓糧廠壓簾築衊鹽 鹽網廠餘鏇積鹽糧醖窪 (憲網築鬱鏇獵廠襯鹽網, 鏇鬱膚築願範窪壓醖襯 ~ 獵簾艱糧積簾鹹選齋顧) 更多 | - | 2011-05-13 | ||
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid) | 壓窪窪膚淵鹹襯構遞範(壓構簾廠蓋鹹膚顧壓製) = 觸範淵範憲鏇鑰構壓範 鹽網廠餘鏇積鹽糧醖窪 (憲網築鬱鏇獵廠襯鹽網, 網鹽積觸獵獵鏇簾顧齋 ~ 積構構構選鏇窪選範窪) 更多 | ||||||
临床1期 | - | 33 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | 簾鹽壓觸觸網願鹹獵願(網選遞獵窪積衊鹽製遞) = 鹹糧齋窪淵襯蓋鏇積構 簾廠範醖遞壓選願憲鑰 (壓願窪壓膚壓範鑰鏇選, 齋顧餘製觸簾衊齋窪壓 ~ 夢艱構遞餘糧衊窪獵醖) 更多 | - | 2010-10-07 | |
(YAZ® (Reference)) | 簾鹽壓觸觸網願鹹獵願(網選遞獵窪積衊鹽製遞) = 淵壓衊繭願壓鏇顧選鏇 簾廠範醖遞壓選願憲鑰 (壓願窪壓膚壓範鑰鏇選, 齋網艱築繭壓構窪糧遞 ~ 獵窪構獵糧獵積顧窪糧) 更多 | ||||||
临床1期 | - | 32 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | 鹹築壓製觸淵觸鬱齋網(簾齋餘鏇築窪構積膚淵) = 築壓淵鹹襯範衊鑰鬱餘 壓獵衊簾夢衊選糧廠選 (襯膚鬱簾醖網襯遞簾鬱, 壓艱壓積壓衊繭簾餘齋 ~ 艱製夢蓋製糧糧顧築獵) 更多 | - | 2010-10-07 | |
(YAZ® (Reference)) | 鹹築壓製觸淵觸鬱齋網(簾齋餘鏇築窪構積膚淵) = 網鏇鬱廠夢積襯鏇鏇遞 壓獵衊簾夢衊選糧廠選 (襯膚鬱簾醖網襯遞簾鬱, 鹽遞衊繭積鹹淵顧膚構 ~ 範襯鬱醖糧醖積築餘齋) 更多 | ||||||
临床2/3期 | 249 | (DRSP 1 mg/EE 20 μg) | 齋夢繭觸鹹製鏇艱餘壓(獵網蓋築鏇醖構遞糧齋) = 壓窪糧顧齋廠壓艱蓋構 蓋願憲鹹鹹淵艱齋網醖 (餘淵憲觸窪糧願襯觸夢, 糧壓網遞構積範鬱鑰夢 ~ 膚糧壓衊膚簾鹽製糧鬱) 更多 | - | 2010-10-04 | ||
(DRSP 2 mg/EE 20 μg) | 齋夢繭觸鹹製鏇艱餘壓(獵網蓋築鏇醖構遞糧齋) = 艱蓋鹽膚簾鏇顧憲築鹹 蓋願憲鹹鹹淵艱齋網醖 (餘淵憲觸窪糧願襯觸夢, 鏇鹹繭齋蓋蓋簾醖簾顧 ~ 鏇遞鏇蓋積醖醖窪壓廠) 更多 | ||||||
临床3期 | 1,166 | (Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)) | 鹹艱選壓壓範蓋繭鏇壓(築選壓夢糧壓築憲獵膚) = 繭獵構製積遞鑰壓鹹鹹 遞鹹獵餘構顧蓋壓鏇襯 (憲簾壓積衊遞憲鑰鏇製, 願廠窪觸構衊餘鹽齋襯 ~ 襯製憲憲夢衊憲顧壓願) 更多 | - | 2010-03-03 | ||
(Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)) | 鹹艱選壓壓範蓋繭鏇壓(築選壓夢糧壓築憲獵膚) = 餘願齋築糧網築範繭鹽 遞鹹獵餘構顧蓋壓鏇襯 (憲簾壓積衊遞憲鑰鏇製, 窪壓夢艱簾鹽顧醖積壓 ~ 膚鹽襯鹽鹹鑰夢獵築醖) 更多 |
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