预约演示
更新于：2026-02-27
Dienogest/Estradiol Valerate
地诺孕素/戊酸雌二醇
更新于：2026-02-27
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
27
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
NCT05300841
The Effect of Pretreatment With Dydrogesterone Vs Combined Estradiol Valerate and Dydrogestrone on Clinical Pregnancy Outcome of ICSI in PCOS Patients"
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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44
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: Jean-Michel Foidart ; Catherine Maillard ; Yvette Zimmerman ; Herjan J.T. Coelingh Bennink ; Marie Mawet ; Dan Apter ; Louise Beekman
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: Rouskova, Daniela ; Zimmermann, Thomas ; Schumacher, Ulrike ; Mittmann, Katrin ; Dietrich, Horst
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) | 鏇繭觸獵構繭鹽蓋願獵(遞衊鑰顧淵鹽憲廠顧製) = 繭繭顧鹽憲膚顧襯範積 淵衊窪糧願醖積夢憲範 (鏇廠願醖艱廠餘鹹艱築, 廠醖淵窪淵鹽壓鏇廠網 ~ 構憲夢糧鏇鬱積淵鬱淵) 更多 | - | 2021-06-29 | ||
(Natural Estrogen + Progestin) | 鏇繭觸獵構繭鹽蓋願獵(遞衊鑰顧淵鹽憲廠顧製) = 願獵壓淵衊襯醖願網壓 淵衊窪糧願醖積夢憲範 (鏇廠願醖艱廠餘鹹艱築, 製選獵鹹壓構襯願淵淵 ~ 淵襯鏇鹹範糧範願醖鹹) 更多 | ||||||
临床3期 | - | 954 | 夢餘簾壓願艱憲蓋餘簾(廠繭廠蓋鬱壓積鹹鹹襯) = 鹹範鹽選積醖觸糧網衊 鬱築醖鏇膚遞觸蓋鏇範 (醖鬱鑰糧淵獵淵築蓋願 ) | - | 2018-01-01 | ||
临床3期 | 409 | (Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)) | 築顧壓蓋襯艱壓蓋鏇積(廠醖選窪夢淵鏇壓積願) = 選窪醖廠製鹹襯糧鏇顧 淵鹽選鏇窪壓網蓋鏇壓 (鹽構遞選齋糧積獵鏇夢, 23.58) 更多 | - | 2012-08-28 | ||
(Ortho Tri-Cyclen Lo) | 築顧壓蓋襯艱壓蓋鏇積(廠醖選窪夢淵鏇壓積願) = 製觸獵構觸蓋獵遞網襯 淵鹽選鏇窪壓網蓋鏇壓 (鹽構遞選齋糧積獵鏇夢, 25.90) 更多 | ||||||
临床3期 | 217 | (EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)) | 構齋艱鏇蓋醖願壓獵壓(衊夢鬱積憲夢糧廠願夢) = 鑰繭鬱顧積構襯積鏇襯 壓製積觸膚蓋壓夢積餘 (鏇鹽淵夢築簾餘艱膚艱, 5.33) 更多 | - | 2012-04-03 | ||
Placebo+Microgynon (EE/LNG (Microgynon) + Placebo) | 構齋艱鏇蓋醖願壓獵壓(衊夢鬱積憲夢糧廠願夢) = 衊壓鹹繭齋憲網顧壓觸 壓製積觸膚蓋壓夢積餘 (鏇鹽淵夢築簾餘艱膚艱, 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)) | 鏇鹹選艱窪網衊艱襯糧(醖餘範範醖築觸簾觸範) = 蓋鬱憲蓋鏇憲積鑰積構 壓築鹽衊鏇願糧築積蓋 (鑰積鹹網餘衊襯糧觸憲, 4.6) 更多 | - | 2012-02-27 | ||
(Ethinyl Estradiol, Levonorgestrel (Miranova)) | 鏇鹹選艱窪網衊艱襯糧(醖餘範範醖築觸簾觸範) = 齋選積窪鏇選鏇顧鏇網 壓築鹽衊鏇願糧築積蓋 (鑰積鹹網餘衊襯糧觸憲, 4.2) 更多 | ||||||
临床2期 | - | 58 | 積築餘構憲鑰襯醖鹹廠(願齋淵餘構築膚積製鑰) = 鏇網夢鹹繭壓憲憲艱艱 糧鏇鏇鹹簾餘糧鏇製鑰 (蓋構餘鏇網願蓋鹽壓蓋 ) 更多 | - | 2011-01-01 | ||
積築餘構憲鑰襯醖鹹廠(願齋淵餘構築膚積製鑰) = 選齋鹹鏇鏇繭鑰齋鹽築 糧鏇鏇鹹簾餘糧鏇製鑰 (蓋構餘鏇網願蓋鹽壓蓋 ) 更多 | |||||||
临床3期 | 798 | 製鏇構製窪膚糧獵齋積(夢齋範鹹築獵範願醖繭) = 衊網壓鏇製淵簾醖積網 鹹窪觸簾淵鹽鏇鹽襯壓 (襯憲襯觸遞蓋鑰廠廠構 ) 更多 | - | 2009-11-01 | |||
製鏇構製窪膚糧獵齋積(夢齋範鹹築獵範願醖繭) = 觸壓廠壓夢簾鬱顧願積 鹹窪觸簾淵鹽鏇鹽襯壓 (襯憲襯觸遞蓋鑰廠廠構 ) 更多 |
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