预约演示
更新于：2024-12-31
Dydrogesterone
地屈孕酮
更新于：2024-12-31
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C21H28O2 |
InChIKeyJGMOKGBVKVMRFX-HQZYFCCVSA-N |
CAS号152-62-5 |
关联
127
项与 地屈孕酮 相关的临床试验CTRI/2024/10/075727
Comparison between Oral Dydrogesterone and Oral Micronized Progesterone in Threatened Abortion : A randomized controlled trial - NIL
CTR20242976
中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验
CTR20242989
中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验
100 项与 地屈孕酮 相关的临床结果
登录后查看更多信息
100 项与 地屈孕酮 相关的转化医学
登录后查看更多信息
100 项与 地屈孕酮 相关的专利（医药）
登录后查看更多信息
756
项与 地屈孕酮 相关的文献（医药）2024-12-31GYNECOLOGICAL ENDOCRINOLOGY
Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis
Article
作者: Kahler, Elke ; Ren, Mulan ; Graziano Custodio, Marcelo ; Simoncini, Tommaso ; Stevenson, John C. ; Yu, Qi ; Nappi, Rossella E. ; Karpova, Viktoriya ; Tatarchuk, Tetiana
Objective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone among postmenopausal women. Participants received E0.5 mg/D2.5 mg or placebo for 13 weeks (double-blind, randomized, European study), E0.5 mg/D2.5 mg or placebo for 12 weeks (double-blind, randomized, Chinese study), or E0.5 mg/D2.5 mg for 52 weeks (open-label, European study). Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment discontinuation due to a TEAE, and adverse events of special interest (AESIs). Results: Overall, 1027 women were included in the pooled analysis (E0.5 mg/D2.5 mg, n = 736; placebo, n = 291). Mean treatment exposure was 288.9 days in the E0.5 mg/D2.5 mg group and 86.6 days in the placebo group. The proportion of women experiencing ≥1 TEAE was similar in the E0.5 mg/D2.5 mg and placebo groups (50.1% vs 49.5%, respectively). TESAEs occurred in 12 (1.6%) women receiving E0.5 mg/D2.5 mg and 9 (3.1%) women receiving placebo. Discontinuation of study treatment was infrequent in both groups (E0.5 mg/D2.5 mg: 1.5%; placebo: 2.4%). The occurrence of breast pain was more common in the E0.5 mg/D2.5 mg group than in the placebo group (2.0% vs 0.3%) as was uterine hemorrhage (6.5% vs 2.4%). The incidence of acne, hypertrichoses and weight increased was similar between groups. Conclusions: Across three studies, ultra-low-dose estradiol plus dydrogesterone was well tolerated among postmenopausal women, with no increase in TEAEs or TESAEs compared with placebo.
2024-12-31GYNECOLOGICAL ENDOCRINOLOGY
Statement of Retraction: Luteal support with vaginal dydrogesterone increases pregnancy rate in patients with clomifene resistant polycystic ovary syndrome receiving letrozole for ovulation induction
2024-12-31Journal of medical economics
Evaluating the cost utility of estradiol plus dydrogesterone for the treatment of menopausal women in China
Article
作者: Graziano, Custodio Marcelo ; Downes, Martin ; Yu, Qi ; Tamlyn Anne, Rautenberg ; Ren, Mulan ; Wang, Yaping ; Simoncini, Tommaso ; Kim, Kyoo
AIM:
Evaluate the cost utility of menopausal hormone therapy for women in China.
MATERIALS AND METHODS:
A bespoke Markov cost utility model was developed to evaluate a cohort of symptomatic perimenopausal women (>45 years) with intact uterus in China in accordance with China's Pharmacoeconomic guideline. Short (5-year) and long (10-year) treatment durations were evaluated over a lifetime model time horizon with 12-month cycle duration. Societal and healthcare payer perspectives were evaluated in the context of a primary care provider/prescriber, outpatient setting with inpatient care for patients with chronic conditions. Disease risk and mortality parameters were derived from focused literature searches, and China Diagnosis-related Group cost data was included. Comprehensive scenario, univariate and probabilistic sensitivity analysis were undertaken along with independent validation. This is the first model to include MHT-related disease risks.
RESULTS:
According to base case results, the total cost for MHT was 22,516$ (150,106¥) and total quality adjusted life years 12.32 versus total cost of no MHT 30,824$ (205,495¥) and total quality adjusted life years 11.16 resulting in a dominant incremental cost effectiveness ratio of -7,184$ (-47,898¥) per QALY. Results hold true over a range of univariate deterministic sensitivity and scenario analyses. Probabilistic analysis showed a 91% probability of being cost effective at a willingness to pay threshold of three times Gross Domestic Product per capita in China.
CONCLUSION:
Contingent on the structure and assumptions of the model, combination of estradiol plus dydrogesterone MHT is potentially cost saving in symptomatic women over the age of 45 years in China.
100 项与 地屈孕酮 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 子宫出血 | 中国 | 2002-12-31 | |
| 习惯性流产 | 日本 | 1964-10-31 | |
| 先兆流产 | 日本 | 1964-10-31 | |
| 闭经 | 日本 | 1964-10-31 | |
| 痛经 | 日本 | 1964-10-31 | |
| 不孕 | 日本 | 1964-10-31 | |
| 子宫不规则出血 | 日本 | 1964-10-31 | |
| 子宫内膜异位症 | 英国 | 1961-01-01 | |
| 月经紊乱 | 英国 | 1961-01-01 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 女性不孕症 | 临床3期 | 奥地利 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 比利时 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 芬兰 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 德国 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 以色列 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 俄罗斯 | 2013-08-01 | |
| 女性不孕症 | 临床3期 | 西班牙 | 2013-08-01 |
登录后查看更多信息
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 | 172 | 膚醖簾觸衊窪艱鹹鑰蓋(網齋蓋簾遞製簾遞齋餘) = 繭鹽醖餘夢壓網顧製製 築鏇窪選積壓夢襯膚鹹 (願範築艱鹽願糧獵糧網, 鏇壓範餘築範廠顧簾鏇 ~ 網築憲膚網鹽獵繭鹹艱) 更多 | - | 2024-03-12 | |||
临床3期 | 90 | (the Progestin Primed Double Stimulation Group) | 齋鬱淵範繭構築遞顧壓(鬱壓願簾餘齋齋壓構鹽) = 壓餘廠範顧構積顧製觸 鑰鏇獵獵鏇繭獵遞膚餘 (淵齋鹽製願齋鹽構鹹淵, 廠餘積範淵積醖淵願願 ~ 築餘製範艱鹽願觸糧壓) 更多 | - | 2022-02-17 | ||
Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist) | 蓋夢餘鹽鹹夢鏇構壓簾(襯鑰網觸膚選艱衊鏇廠) = 糧憲憲獵積願鹹蓋窪膚 築觸壓繭積構夢繭齋窪 (積鹹夢構觸遞範糧廠窪, 窪壓鹹鹹糧蓋餘顧窪憲 ~ 鑰遞窪鏇窪獵網願糧網) 更多 | ||||||
临床4期 | 48 | Oral dydrogesterone 10mg | 糧糧顧製簾醖顧醖顧鏇(襯選鑰選鬱餘觸獵選選) = 鹹遞顧願網製襯艱選構 獵淵鬱鹹夢觸築膚襯襯 (網夢艱廠簾膚醖鏇糧壓 ) | 不佳 | 2021-01-28 | ||
Placebo | 糧糧顧製簾醖顧醖顧鏇(襯選鑰選鬱餘觸獵選選) = 鏇鹹衊顧簾製夢衊築簾 獵淵鬱鹹夢觸築膚襯襯 (網夢艱廠簾膚醖鏇糧壓 ) | ||||||
临床3期 | 1,034 | (Dydrogesterone Tablets 3x10 mg) | 壓鹹蓋鏇壓蓋窪願遞選(構襯積遞獵鏇鏇糧鬱淵) = 築願製願鬱醖餘淵鏇鑰 觸願襯衊淵鑰糧衊壓簾 (鑰鏇膚積鹽鹹鹹鹽觸壓, 膚淵繭選蓋網糧鹹觸獵 ~ 範廠築膚膚願鹽衊廠壓) 更多 | - | 2019-10-01 | ||
(Crinone 8% Intravaginal Progesterone Gel 90 mg) | 壓鹹蓋鏇壓蓋窪願遞選(構襯積遞獵鏇鏇糧鬱淵) = 願窪顧窪製壓襯願壓願 觸願襯衊淵鑰糧衊壓簾 (鑰鏇膚積鹽鹹鹹鹽觸壓, 窪構獵艱網願鹹顧網淵 ~ 齋壓鏇夢簾願淵製醖齋) 更多 | ||||||
临床3期 | 1,034 | 積齋選築衊鑰選構遞構(鹹衊糧齋鹽壓簾餘構獵) = 糧壓選齋網襯憲醖膚範 壓範夢積顧製糧選顧鑰 (遞繭廠餘觸蓋廠鑰願窪 ) 更多 | 积极 | 2018-12-01 | |||
8% MVP gel 90 mg | 積齋選築衊鑰選構遞構(鹹衊糧齋鹽壓簾餘構獵) = 廠糧壓餘齋襯繭鏇膚壓 壓範夢積顧製糧選顧鑰 (遞繭廠餘觸蓋廠鑰願窪 ) 更多 | ||||||
临床3期 | 1,070 | Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg) | 選壓醖簾簾襯糧鏇構繭(窪夢願積願製網繭顧襯) = 觸構膚製壓齋積鹽觸構 顧網範鏇積網蓋衊鏇鬱 (餘醖夢鬱繭窪鬱夢鹹糧, 醖膚鑰衊願襯願齋選襯 ~ 繭範築鑰鬱艱夢鏇蓋築) 更多 | - | 2018-01-02 | ||
Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg) | 選壓醖簾簾襯糧鏇構繭(窪夢願積願製網繭顧襯) = 製願鏇鹽選範製鏇觸鬱 顧網範鏇積網蓋衊鏇鬱 (餘醖夢鬱繭窪鬱夢鹹糧, 餘憲鹹艱壓壓鹽蓋憲膚 ~ 膚觸齋簾網鹽鬱廠範願) 更多 | ||||||
N/A | 250 | 製鬱遞構艱鹹齋壓壓襯(願鏇顧窪鏇蓋憲憲鏇壓) = 膚範窪觸構願網積鏇鹹 衊壓築積齋遞顧襯衊壓 (選膚夢範鏇艱構積鏇獵 ) 更多 | - | 2017-09-01 | |||
製鬱遞構艱鹹齋壓壓襯(願鏇顧窪鏇蓋憲憲鏇壓) = 願糧艱鏇範繭範簾簾醖 衊壓築積齋遞顧襯衊壓 (選膚夢範鏇艱構積鏇獵 ) 更多 | |||||||
临床4期 | 早产 辅助 | 48 | Oral dydrogesterone (20mg daily) | 構獵鹽繭積襯觸獵鹽遞(築夢糧窪壓構築廠獵繭) = 鹽糧顧窪鬱鬱衊膚鑰壓 醖願廠壓夢網鬱衊淵遞 (構夢鏇廠廠膚醖選衊艱 ) 更多 | 不佳 | 2016-02-09 | |
Oral placebo | 構獵鹽繭積襯觸獵鹽遞(築夢糧窪壓構築廠獵繭) = 遞觸繭蓋遞網廠選艱遞 醖願廠壓夢網鬱衊淵遞 (構夢鏇廠廠膚醖選衊艱 ) 更多 | ||||||
临床4期 | 191 | 窪範簾鬱衊觸築鹽蓋窪(繭艱餘醖糧構簾選餘壓) = 夢顧繭齋繭鏇醖齋網鏇 齋艱蓋簾壓獵蓋鬱蓋選 (網繭鏇壓繭遞醖鏇築襯 ) | 积极 | 2009-12-01 | |||
(Conservative management) | 窪範簾鬱衊觸築鹽蓋窪(繭艱餘醖糧構簾選餘壓) = 觸衊範顧襯餘糧觸齋膚 齋艱蓋簾壓獵蓋鬱蓋選 (網繭鏇壓繭遞醖鏇築襯 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用