预约演示
更新于：2025-05-24
Dienogest/Estradiol Valerate
地诺孕素/戊酸雌二醇
更新于：2025-05-24
概要
基本信息
原研机构 |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 西班牙 (2001-05-08), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C43H57NO5 |
InChIKeyLRHSUZNWLAJWRT-GAJBHWORSA-N |
CAS号307334-58-3 |
Sequence Code 27661
当前序列信息引自: *****
关联
26
项与 地诺孕素/戊酸雌二醇 相关的临床试验TCTR20240908003
A comparison of menstrual volume and other benefits between Estradiol valerate/dienogest and Ethinyl estradiol/desogestrel: A randomized controlled trial
NCT06396208
"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition: A Single-blind, Randomized Controlled, Non-inferiority Trial
NCT05332106
Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product
100 项与 地诺孕素/戊酸雌二醇 相关的临床结果
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100 项与 地诺孕素/戊酸雌二醇 相关的转化医学
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100 项与 地诺孕素/戊酸雌二醇 相关的专利（医药）
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59
项与 地诺孕素/戊酸雌二醇 相关的文献（医药）2016-10-01Contraception2区 · 医学
Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA)
2区 · 医学
Article
作者: Mawet, Marie ; Coelingh Bennink, Herjan J T ; Maillard, Catherine ; Zimmerman, Yvette ; Foidart, Jean-Michel ; Apter, Dan ; Beekman, Louise
OBJECTIVES:
This study aims to assess vaginal bleeding patterns and cycle control of oral contraceptives containing estetrol (E4) combined with either drospirenone (DRSP) or levonorgestrel (LNG).
STUDY DESIGN:
An open-label, multicentre, randomised, dose-finding study lasting six cycles in healthy women aged 18-35 years was used. Four treatments (15 mg or 20 mg E4, combined with either 3 mg DRSP or 150 mcg LNG) were administered in a 24/4-day regimen. A marketed dosing regimen of estradiol valerate with dienogest (E2V/DNG) served as reference since it contains (like E4) a natural oestrogen.
RESULTS:
A total of 396 women were randomised, of whom 389 received study medication, and 316 completed the study. By cycle 6, the frequencies of unscheduled bleeding and/or spotting and absence of withdrawal bleeding were the lowest in the 15 mg E4/DRSP group (33.8% and 3.5%, respectively). In the E2V/DNG reference group, these frequencies were 47.8% and 27.1%, respectively. By cycle 6, the frequency of women with absence of withdrawal bleeding was <20% for all E4 treatment groups: 3.5-3.8% combined with DRSP and 14.0-18.5% combined with LNG. By cycle 6, unscheduled intracyclic bleeding was reported by <20% of women in the 20 mg E4/LNG group (18.9%) and in the 15 mg E4/DRSP group (16.9%).
CONCLUSION:
This study showed that, of the four treatment modalities investigated, the 15 mg E4/DRSP combination has the most favourable bleeding pattern and cycle control.
IMPLICATIONS:
Due to its favourable bleeding pattern and cycle control, the 15 mg E4/DRSP combination is the preferred combination for further phase III clinical development.
2015-10-01Archives of gynecology and obstetrics4区 · 医学
Are hormonal components of oral contraceptives associated with impaired female sexual function? A questionnaire-based online survey of medical students in Germany, Austria, and Switzerland
4区 · 医学
Article
作者: Schoenfisch, Birgitt ; Mueck, Alfred O. ; Wallwiener, Markus ; Wallwiener, Lisa-Maria ; Wallwiener, Christian W. ; Zipfel, Stephan ; Brucker, Sara Y. ; Taran, Florin-Andrei ; Bitzer, Johannes ; Seeger, Harald
PURPOSE:
To investigate in a large cohort of young university women whether different progestins and different ethinyl estradiol (EE) dosages in oral hormonal contraceptives (OHCs) adversely affect sexual function.
METHODS:
Female medical students from German, Austrian, and Swiss universities (14/1/1) completed an anonymous online questionnaire comprising the 19 Female Sexual Function Index (FSFI) questions and 17 additional questions concerning demographics, lifestyle, sexual activity, and contraceptive use. OHCs were categorized by EE dose (≤20, <20 to ≤30, and >30 µg) and partially androgenic or antiandrogenic progestins. FSFI scores were analyzed by contraceptive method using descriptive statistics and standard nonparametric tests.
RESULTS:
We analyzed 2612 questionnaires submitted by respondents aged ≤30 years [mean age (SD) 23.5 (2.5) years]. Of 2126 contraceptive users, 1535 (72.2 %) used OHCs. Median FSFI total scores (ranges) were 28.2 (2.0-36.0) for all respondents. Median FSFI was significantly lower in non-users (24.4) versus users (28.7) of contraception (p < 0.001). Stratified analysis showed that 279/486 (57.4 %) respondents using no contraceptives, 563/1535 (36.7 %) using OHCs, 71/227 (31.3 %) using non-oral hormonal contraceptives, and 96/351 (27.4 %) using non-hormonal contraceptives were at risk for female sexual dysfunction (FSFI total score <26.55). FSFI scores for the three EE dosage categories and progestin components did not differ significantly.
CONCLUSIONS:
For OHCs, the FSFI score was lower than for other contraceptives but there was no significant association with EE dose or progestins, possibly due to small sample sizes. Further research needs to clarify the role of OHCs in female sexual function.
2015-07-01Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology4区 · 医学
Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a non-interventional observational study over 6 cycles of 28 days.
4区 · 医学
Article
作者: Daniela Rouskova ; Katrin Mittmann ; Thomas Zimmermann ; Ulrike Schumacher ; Horst Dietrich
BACKGROUND:
Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.
METHODS:
Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.
RESULTS:
MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medication's effectiveness/tolerability as good/very good; 84% intended to continue the treatment.
CONCLUSION:
This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency.
100 项与 地诺孕素/戊酸雌二醇 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 |
|---|---|---|---|
| 月经过多 | 美国 | 2012-03-14 | |
| 避孕 | 澳大利亚 | 2009-05-14 | |
| 雌激素缺乏症状 | 荷兰 | 2001-05-08 | |
| 雌激素缺乏症状 | 葡萄牙 | 2001-05-08 | |
| 雌激素缺乏症状 | 西班牙 | 2001-05-08 |
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 |
|---|---|---|---|---|
| 子宫不规则出血 | 临床3期 | 中国 | 2012-06-01 | |
| 子宫不规则出血 | 临床3期 | 菲律宾 | 2012-06-01 | |
| 子宫不规则出血 | 临床3期 | 俄罗斯 | 2012-06-01 | |
| 子宫不规则出血 | 临床3期 | 新加坡 | 2012-06-01 | |
| 子宫不规则出血 | 临床3期 | 中国台湾 | 2012-06-01 | |
| 子宫不规则出血 | 临床3期 | 泰国 | 2012-06-01 | |
| 原发性痛经 | 临床3期 | 美国 | 2009-04-01 | |
| 原发性痛经 | 临床3期 | 加拿大 | 2009-04-01 | |
| 原发性痛经 | 临床3期 | 智利 | 2009-04-01 | |
| 原发性痛经 | 临床3期 | 意大利 | 2009-04-01 |
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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4期 | 59 | (Synthetic Estrogen + Progestin) | 廠窪範願網蓋簾範願繭(襯鬱壓膚衊願選壓憲築) = 鹹願糧窪淵糧鑰鏇願鑰 廠糧廠鏇構廠鏇鏇網願 (範繭糧鏇繭糧餘襯顧艱, 網襯醖製積憲醖製鬱鏇 ~ 鹽鬱醖鏇蓋鹹糧糧壓淵) 更多 | - | 2021-06-29 | ||
(Natural Estrogen + Progestin) | 廠窪範願網蓋簾範願繭(襯鬱壓膚衊願選壓憲築) = 糧壓鏇膚築繭艱顧淵淵 廠糧廠鏇構廠鏇鏇網願 (範繭糧鏇繭糧餘襯顧艱, 網蓋鹹糧餘積齋遞鏇獵 ~ 壓顧鹹製廠餘築襯選鑰) 更多 | ||||||
临床3期 | - | 954 | 網艱衊簾鬱憲淵構淵簾(襯廠鹽艱艱積構願觸簾) = 鏇齋選壓鬱鏇膚憲構鏇 壓衊範網鹹鑰膚夢構糧 (壓積憲簾築網艱獵鬱窪 ) | - | 2018-01-01 | ||
临床3期 | 409 | (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | 鏇鏇遞積範鏇鹽襯憲簾(顧遞簾糧積構夢淵窪積) = 鏇觸窪築構鹹鬱衊糧淵 鏇鑰網鹽壓窪夢鏇窪鬱 (築蓋糧獵膚夢憲遞蓋積, 23.58) 更多 | - | 2012-08-28 | ||
(Ortho Tri-Cyclen Lo) | 鏇鏇遞積範鏇鹽襯憲簾(顧遞簾糧積構夢淵窪積) = 觸艱顧衊餘淵鏇積構觸 鏇鑰網鹽壓窪夢鏇窪鬱 (築蓋糧獵膚夢憲遞蓋積, 25.90) 更多 | ||||||
临床3期 | 217 | (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)) | 鹽鏇觸顧憲鬱積膚範願(鹽繭觸築鹹範淵網壓鹽) = 顧繭壓積網製繭鬱鏇襯 齋鏇獵廠製廠淵鏇窪製 (窪夢積構範憲糧製選網, 5.33) 更多 | - | 2012-04-03 | ||
Placebo+Microgynon (EE/LNG (Microgynon) + Placebo) | 鹽鏇觸顧憲鬱積膚範願(鹽繭觸築鹹範淵網壓鹽) = 範選齋夢憲膚鑰鏇積醖 齋鏇獵廠製廠淵鏇窪製 (窪夢積構範憲糧製選網, 6.22) 更多 | ||||||
临床3期 | 507 | Placebo Match to SH T00658ID+Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | 願醖艱襯膚廠襯醖積憲(選蓋衊簾艱積艱衊夢餘) = 簾鹹顧蓋顧製淵齋遞餘 範膚襯鹹醖獵糧廠築鑰 (廠觸觸範獵繭醖鹽築製, 4.6) 更多 | - | 2012-02-27 | ||
Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova)) | 願醖艱襯膚廠襯醖積憲(選蓋衊簾艱積艱衊夢餘) = 獵構範齋鹽築廠範構蓋 範膚襯鹹醖獵糧廠築鑰 (廠觸觸範獵繭醖鹽築製, 4.2) 更多 | ||||||
临床2期 | - | 58 | 遞窪簾顧顧顧憲齋醖繭(繭廠選選廠鬱鑰糧糧構) = 遞網鹽衊築鹹鏇網獵窪 廠淵製顧壓餘製糧鬱醖 (遞積鹹鹹糧簾築鹽壓構 ) 更多 | - | 2011-01-01 | ||
遞窪簾顧顧顧憲齋醖繭(繭廠選選廠鬱鑰糧糧構) = 簾範構範餘簾選選壓製 廠淵製顧壓餘製糧鬱醖 (遞積鹹鹹糧簾築鹽壓構 ) 更多 | |||||||
临床3期 | 798 | 網襯鬱鏇餘鏇鬱願蓋遞(夢淵繭衊夢艱壓構衊壓) = 淵餘廠淵網積艱壓鑰鹽 願醖鏇壓鏇積構淵鏇築 (獵齋窪壓築窪觸齋網觸 ) 更多 | - | 2009-11-01 | |||
網襯鬱鏇餘鏇鬱願蓋遞(夢淵繭衊夢艱壓構衊壓) = 蓋願簾夢選獵餘廠獵構 願醖鏇壓鏇積構淵鏇築 (獵齋窪壓築窪觸齋網觸 ) 更多 |
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