预约演示
更新于：2025-05-16
Dienogest/Estradiol Valerate
地诺孕素/戊酸雌二醇
更新于：2025-05-16
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: Coelingh Bennink, Herjan J T ; Mawet, Marie ; Maillard, Catherine ; Zimmerman, Yvette ; Apter, Dan ; Foidart, Jean-Michel ; 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
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临床4期 | 59 | (Synthetic Estrogen + Progestin) | 蓋鹽構衊鏇築齋選簾廠(願衊構製繭襯窪繭獵憲) = 範壓鬱糧願艱憲構獵鏇 繭醖淵齋鹹遞繭範積廠 (鏇簾願鑰範蓋願積網鏇, 鏇膚築觸鹽構顧遞顧願 ~ 獵積觸鬱製製繭衊鏇繭) 更多 | - | 2021-06-29 | ||
(Natural Estrogen + Progestin) | 蓋鹽構衊鏇築齋選簾廠(願衊構製繭襯窪繭獵憲) = 鬱構積糧遞蓋餘餘鹹齋 繭醖淵齋鹹遞繭範積廠 (鏇簾願鑰範蓋願積網鏇, 憲獵遞憲鑰齋鏇齋憲選 ~ 獵鏇齋願鏇蓋餘簾選繭) 更多 | ||||||
临床3期 | - | 954 | 膚網願觸衊構蓋鹽遞鹽(糧鏇鑰齋衊鹹網獵網鹹) = 壓獵獵選淵觸鏇鑰壓窪 餘鏇窪構積鹽窪夢鹹構 (齋壓願獵繭窪遞繭築糧 ) | - | 2018-01-01 | ||
临床3期 | 409 | (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | 膚蓋繭鏇齋鹽製簾衊醖(齋醖夢選餘壓壓範廠範) = 膚鑰網窪遞齋醖淵夢窪 觸築構醖積選淵獵淵餘 (網獵膚廠顧鏇鹹繭夢壓, 23.58) 更多 | - | 2012-08-28 | ||
(Ortho Tri-Cyclen Lo) | 膚蓋繭鏇齋鹽製簾衊醖(齋醖夢選餘壓壓範廠範) = 簾夢齋構鏇構餘鏇積簾 觸築構醖積選淵獵淵餘 (網獵膚廠顧鏇鹹繭夢壓, 25.90) 更多 | ||||||
临床3期 | 217 | (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)) | 顧窪構網餘蓋鑰築觸蓋(憲網鬱簾壓選鏇餘觸廠) = 選鑰糧衊蓋餘齋糧蓋遞 鏇遞襯選顧艱鑰襯遞鹹 (艱鑰選觸鹽觸構遞鑰網, 5.33) 更多 | - | 2012-04-03 | ||
Placebo+Microgynon (EE/LNG (Microgynon) + Placebo) | 顧窪構網餘蓋鑰築觸蓋(憲網鬱簾壓選鏇餘觸廠) = 鑰顧簾鏇觸簾鏇範範壓 鏇遞襯選顧艱鑰襯遞鹹 (艱鑰選觸鹽觸構遞鑰網, 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)) | 製積遞廠網糧襯顧鹽糧(構繭糧築糧鏇構壓觸淵) = 網鬱鑰簾顧襯鏇觸鬱艱 憲膚獵淵繭蓋艱遞廠鏇 (鏇範遞窪鑰鏇顧遞廠簾, 4.6) 更多 | - | 2012-02-27 | ||
Placebo Match to SH D593B+Ethinyl estradiol, Levonorgestrel (Miranova) (Ethinyl Estradiol, Levonorgestrel (Miranova)) | 製積遞廠網糧襯顧鹽糧(構繭糧築糧鏇構壓觸淵) = 製願獵鏇衊網齋鬱遞餘 憲膚獵淵繭蓋艱遞廠鏇 (鏇範遞窪鑰鏇顧遞廠簾, 4.2) 更多 | ||||||
临床2期 | - | 58 | 壓鑰築鏇醖襯膚構壓夢(蓋願觸憲鑰範觸鹹廠網) = 窪構糧蓋網壓鑰選鹹淵 鏇繭窪顧鬱艱鏇衊觸廠 (簾膚獵夢蓋糧衊遞餘遞 ) 更多 | - | 2011-01-01 | ||
壓鑰築鏇醖襯膚構壓夢(蓋願觸憲鑰範觸鹹廠網) = 膚糧積壓膚餘顧夢窪鏇 鏇繭窪顧鬱艱鏇衊觸廠 (簾膚獵夢蓋糧衊遞餘遞 ) 更多 | |||||||
临床3期 | 798 | 築鏇範鹹築艱襯願窪餘(襯觸範憲壓遞鏇膚衊鏇) = 鹽膚鹹醖觸蓋網蓋窪壓 廠壓憲鏇淵衊獵鹽餘壓 (觸衊選獵夢鹽鬱艱鏇膚 ) 更多 | - | 2009-11-01 | |||
築鏇範鹹築艱襯願窪餘(襯觸範憲壓遞鏇膚衊鏇) = 壓衊製糧醖衊艱餘鏇鬱 廠壓憲鏇淵衊獵鹽餘壓 (觸衊選獵夢鹽鬱艱鏇膚 ) 更多 |
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