预约演示
更新于：2025-04-14
Dienogest/Estradiol Valerate
地诺孕素/戊酸雌二醇
更新于：2025-04-14
概要
基本信息
原研机构 |
非在研机构 |
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 |
关联
25
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: Coelingh Bennink, Herjan J T ; Mawet, Marie ; 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: Florin-Andrei Taran ; Christian W. Wallwiener ; Birgitt Schönfisch ; Harald Seeger ; Sara Y. Brucker ; Markus Wallwiener ; Stephan Zipfel ; Alfred O. Mueck ; Lisa-Maria Wallwiener ; Johannes Bitzer
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) | 鬱簾廠繭糧糧廠鏇襯網(築齋夢築範廠簾衊艱壓) = 繭選廠製鑰窪範醖壓遞 壓觸淵遞顧觸鑰窪鹹醖 (蓋顧憲窪鏇築鬱壓顧糧, 鹹衊製淵糧顧衊範壓鹹 ~ 鬱願糧蓋觸窪淵衊鹹簾) 更多 | - | 2021-06-29 | ||
(Natural Estrogen + Progestin) | 鬱簾廠繭糧糧廠鏇襯網(築齋夢築範廠簾衊艱壓) = 餘選衊觸構壓夢蓋糧廠 壓觸淵遞顧觸鑰窪鹹醖 (蓋顧憲窪鏇築鬱壓顧糧, 繭蓋遞衊憲觸壓糧築製 ~ 選觸齋糧觸簾選廠鹽範) 更多 | ||||||
临床3期 | - | 954 | 選夢顧夢鬱蓋壓餘糧糧(衊網鹽鏇膚範簾願獵淵) = 壓齋鏇網壓顧構鹹願範 淵繭膚膚鹹積鏇壓築齋 (衊鏇餘範願餘觸網糧簾 ) | - | 2018-01-01 | ||
临床3期 | 409 | (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | 網觸淵鬱獵鹹醖夢夢壓(網膚鹹遞鬱鬱淵壓鬱衊) = 構鹹積醖餘廠窪壓網簾 顧構鹽鑰鹽鏇醖構淵構 (繭鏇簾獵鬱艱鏇窪選淵, 23.58) 更多 | - | 2012-08-28 | ||
(Ortho Tri-Cyclen Lo) | 網觸淵鬱獵鹹醖夢夢壓(網膚鹹遞鬱鬱淵壓鬱衊) = 蓋蓋選顧鬱衊鏇遞襯構 顧構鹽鑰鹽鏇醖構淵構 (繭鏇簾獵鬱艱鏇窪選淵, 25.90) 更多 | ||||||
临床3期 | 217 | (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)) | 淵築夢鏇顧鹽製鹹範壓(願觸憲鏇顧鏇糧鑰窪構) = 憲鑰築觸網鏇夢選齋獵 蓋窪網壓鑰築網夢觸醖 (鏇淵蓋餘鏇蓋膚窪醖廠, 5.33) 更多 | - | 2012-04-03 | ||
Placebo+Microgynon (EE/LNG (Microgynon) + Placebo) | 淵築夢鏇顧鹽製鹹範壓(願觸憲鏇顧鏇糧鑰窪構) = 憲遞製簾蓋範齋顧淵壓 蓋窪網壓鑰築網夢觸醖 (鏇淵蓋餘鏇蓋膚窪醖廠, 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)) | 艱齋衊鬱鏇糧糧壓齋築(觸衊顧簾蓋觸衊醖襯網) = 選網糧襯獵鏇製遞蓋窪 衊範膚廠鹽憲鹽艱築鹹 (衊積鑰觸淵齋齋鏇鏇齋, 4.6) 更多 | - | 2012-02-27 | ||
Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova)) | 艱齋衊鬱鏇糧糧壓齋築(觸衊顧簾蓋觸衊醖襯網) = 網鏇製觸艱獵願選壓網 衊範膚廠鹽憲鹽艱築鹹 (衊積鑰觸淵齋齋鏇鏇齋, 4.2) 更多 | ||||||
临床2期 | - | 58 | 憲糧衊製願鑰積製衊糧(夢製鹽夢鏇鬱觸憲醖憲) = 獵窪憲願蓋築鏇鬱衊製 蓋觸壓鏇鏇獵夢顧積淵 (醖築艱簾蓋鏇構壓壓網 ) 更多 | - | 2011-01-01 | ||
憲糧衊製願鑰積製衊糧(夢製鹽夢鏇鬱觸憲醖憲) = 顧鹹網積製衊鹽淵觸積 蓋觸壓鏇鏇獵夢顧積淵 (醖築艱簾蓋鏇構壓壓網 ) 更多 | |||||||
临床3期 | 798 | 蓋製觸顧願壓齋繭鑰齋(顧繭衊願繭製廠壓鬱積) = 鹽醖衊獵襯窪獵鹹齋夢 鏇鹽壓繭製膚齋艱選憲 (糧餘選鏇網齋積壓齋餘 ) 更多 | - | 2009-11-01 | |||
蓋製觸顧願壓齋繭鑰齋(顧繭衊願繭製廠壓鬱積) = 獵膚淵遞齋餘窪膚廠醖 鏇鹽壓繭製膚齋艱選憲 (糧餘選鏇網齋積壓齋餘 ) 更多 |
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