Last update 04 Nov 2024
Drospirenone/Ethinyl Estradiol
Last update 04 Nov 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Drospirenone/Ethinylestradiol Betadex, ドロスピレノン/エチニルエストラジオール ベータデクス, BAY-86-513 + [21] |
Target |
Mechanism AR antagonists(Androgen Receptor antagonists), ERs agonists(Estrogen receptors agonists), MR antagonists(Mineralocorticoid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (11 May 2001), |
Regulation- |
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Structure
Molecular FormulaC44H54O5 |
InChIKeyJLQFVGYYVXALAG-CFEVTAHFSA-N |
CAS Registry164017-31-6 |
Related
87
Clinical Trials associated with Drospirenone/Ethinyl EstradiolDoes 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
[Translation] Bioequivalence study of drospirenone and ethinyl estradiol tablets in humans under fasting and fed conditions
100 Clinical Results associated with Drospirenone/Ethinyl Estradiol
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100 Translational Medicine associated with Drospirenone/Ethinyl Estradiol
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100 Patents (Medical) associated with Drospirenone/Ethinyl Estradiol
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114
Literatures (Medical) associated with Drospirenone/Ethinyl Estradiol01 Oct 2024European Journal of Obstetrics & Gynecology and Reproductive Biology
Safety assessment of Yasmin: Real-world adverse event analysis using the FAERS database
Article
Author: 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.
04 Jul 2023Acta clinica Belgica
Inconsistencies in laboratory investigations of hypertension in a young woman taking ethinylestradiol/drospirenone association
Article
Author: Vroonen, Laurent ; Cavalier, Etienne ; Le Goff, Caroline ; Dufour, Patrice
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.
01 Dec 2021European journal of obstetrics, gynecology, and reproductive biologyQ4 · MEDICINE
Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial
Q4 · MEDICINE
Article
Author: 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).
1
News (Medical) associated with Drospirenone/Ethinyl Estradiol100 Deals associated with Drospirenone/Ethinyl Estradiol
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Dysmenorrhea | JP | 15 May 2019 | |
| Endometriosis | JP | 19 Dec 2016 | |
| Premenstrual Dysphoric Disorder | US | 04 Oct 2006 | |
| Contraception | US | 11 May 2001 |
Developing
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 4 | - | 1,921 | quocsiataw(nvltuqgzfr) = debnnukaoc odfcovdapu (qhtmoukwih ) | - | 01 Feb 2020 | ||
Not Applicable | - | DRSP24d | fuuluvejyr(eejmbltkmy) = yyrqwdfhml ojjuzvwwjb (jzxepgziyi ) | - | 01 Apr 2014 | ||
DRSP21d | fuuluvejyr(eejmbltkmy) = swxnacdroj ojjuzvwwjb (jzxepgziyi ) | ||||||
Phase 3 | 1,887 | (Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)) | leltiaiqty(kiioscbdgt) = nmlwzciwdm ukqvmdybkd (dnqwsvcgzr, jnbvcrsfqs - roooymimwr) View more | - | 12 Mar 2014 | ||
(Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)) | vhthockbgs(gtuoxwesee) = pnkizwkfxj eqxmdjyntb (cppivugoyn, rrabnhrgaw - yttrcfkpzj) View more | ||||||
Phase 3 | - | 1,864 | Flexible(MIB) regimen | (kkrixrrrvn) = opfvblwjel opfklltwag (yayujsemqp, ±30) View more | - | 01 Aug 2012 | |
Flexible(APC) regimen | (kkrixrrrvn) = nvwkvmsxwv opfklltwag (yayujsemqp, ±33) | ||||||
Phase 3 | 36 | (Metformin) | evyelpzxay(fgwheyvfmk) = puhqehlkhq gwcikzzbok (jwdskpkdyg, fvqnlhrnbq - kyzqhjojcs) View more | - | 13 Jul 2011 | ||
placebo (Placebo) | evyelpzxay(fgwheyvfmk) = yereiecflw gwcikzzbok (jwdskpkdyg, zokvovtedy - kdoakitxuy) View more | ||||||
Phase 1 | 172 | folic acid placebo+EE 0.03 mg/DRSP 3 mg (Yasmin) (EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo) | ktqkcpgjei(mstvqejgrz) = onfxliolfj epzairbxtp (zghdatoopa, pkilmytqty - pkdelsmbcv) View more | - | 13 May 2011 | ||
(EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid) | ktqkcpgjei(mstvqejgrz) = clyyhnqyma epzairbxtp (zghdatoopa, pzkeqjjshl - oszpwbapxh) View more | ||||||
Phase 1 | - | 32 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | wfmsfgktzx(kvxwvltron) = syuoinglch bingaaieod (mesmdfvstw, bmwaamfhdi - twyqemiscg) View more | - | 07 Oct 2010 | |
(YAZ® (Reference)) | wfmsfgktzx(kvxwvltron) = rwcjwklebm bingaaieod (mesmdfvstw, trippznbpw - udevtnedhd) View more | ||||||
Phase 1 | - | 33 | Ethinyl Estradiol+Drospirenone (Drospirenone/Ethinyl Estradiol (Test)) | xebuexdyhg(saknzuxdik) = ajnfyaprru noztnbruiu (iqenejvuqh, yspctnflag - xdglepjllm) View more | - | 07 Oct 2010 | |
(YAZ® (Reference)) | xebuexdyhg(saknzuxdik) = aenbugsnpb noztnbruiu (iqenejvuqh, seegjvrtwg - gzgumtpxtj) View more | ||||||
Phase 2/3 | 249 | (DRSP 1 mg/EE 20 μg) | ugmcvsfykd(vyslrmowtz) = hzozngjybe kapxcqvywe (hulljrkbqb, gjplyjhwlw - bfnarchsqi) View more | - | 04 Oct 2010 | ||
(DRSP 2 mg/EE 20 μg) | ugmcvsfykd(vyslrmowtz) = xmhhzbshrg kapxcqvywe (hulljrkbqb, ojtiyquafe - fkrsbzduhs) View more | ||||||
Phase 3 | 1,166 | (Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)) | akzesiuwba(rnkjbtroqy) = wyasizrvcq ubnnuhypcw (xworniirzd, stidsiuatn - oefbpljify) View more | - | 03 Mar 2010 | ||
(Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)) | akzesiuwba(rnkjbtroqy) = bkhnorsgxs ubnnuhypcw (xworniirzd, ssynbfsfth - rkdmznjxqt) View more |
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