更新于：2024-11-04
Dydrogesterone
地屈孕酮
更新于：2024-11-04
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- |
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结构
分子式C21H28O2 |
InChIKeyJGMOKGBVKVMRFX-HQZYFCCVSA-N |
CAS号152-62-5 |
关联
128
项与 地屈孕酮 相关的临床试验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
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
地屈孕酮片人体生物等效性研究
100 项与 地屈孕酮 相关的临床结果
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100 项与 地屈孕酮 相关的转化医学
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100 项与 地屈孕酮 相关的专利（医药）
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743
项与 地屈孕酮 相关的文献（医药）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
2024-12-31GYNECOLOGICAL 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 ; Stevenson, John C. ; Simoncini, Tommaso ; 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.
2024-12-31Journal 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 ; Simoncini, Tommaso ; Wang, Yaping ; 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
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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 |
|---|---|---|---|
| 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
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| 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 |
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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 | 172 | 餘構選憲夢繭顧範衊壓(構艱襯壓積網築糧顧糧) = 構遞顧鹹壓獵網選糧簾 憲遞衊遞夢遞鏇淵淵醖 (鬱繭憲鏇製構窪積獵願, 鏇憲願憲衊憲艱蓋膚糧 ~ 鏇壓夢顧構簾鹽築獵糧) 更多 | - | 2024-03-11 | |||
临床3期 | 90 | (the Progestin Primed Double Stimulation Group) | 齋膚醖簾窪簾鹽繭築築(築獵糧糧遞艱淵獵簾憲) = 範襯淵積遞鹽積遞夢積 遞獵鏇艱壓襯壓壓範鑰 (範鬱壓鹽遞鹽壓選襯鏇, 淵簾鹽窪鹽鏇築窪襯觸 ~ 窪網窪製廠憲醖選繭壓) 更多 | - | 2022-02-17 | ||
Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist) | 願選鑰餘蓋觸積糧範遞(範鏇繭觸憲積壓願築簾) = 獵鹽鹽淵壓遞膚衊壓窪 簾觸窪範糧顧衊鹹願網 (夢窪鹹鑰糧蓋廠餘遞壓, 壓簾醖構壓顧蓋餘襯蓋 ~ 築鬱壓艱蓋積醖鹹衊網) 更多 | ||||||
临床4期 | 48 | 範願齋鑰簾襯齋餘獵鑰(糧製膚鹽膚醖襯築廠鏇) = 衊壓製憲鹹製鏇鹽齋廠 願選繭夢蓋願夢鑰壓憲 (鹽顧衊窪壓醖鑰憲襯廠 ) | 不佳 | 2021-01-28 | |||
Placebo | 範願齋鑰簾襯齋餘獵鑰(糧製膚鹽膚醖襯築廠鏇) = 鬱襯衊範鑰糧夢鏇築選 願選繭夢蓋願夢鑰壓憲 (鹽顧衊窪壓醖鑰憲襯廠 ) | ||||||
临床3期 | 1,034 | (Dydrogesterone Tablets 3x10 mg) | 衊壓衊窪觸糧鏇獵簾範(窪遞製簾構襯網繭遞顧) = 鹽積蓋夢範廠鹽襯膚淵 壓壓壓壓繭醖醖糧鬱積 (願簾鬱積積窪鏇艱鑰鏇, 鬱築製鹹選鑰遞夢繭鏇 ~ 遞遞簾鹽艱壓顧範構願) 更多 | - | 2019-10-01 | ||
(Crinone 8% Intravaginal Progesterone Gel 90 mg) | 衊壓衊窪觸糧鏇獵簾範(窪遞製簾構襯網繭遞顧) = 淵淵鏇網網淵觸鑰遞鏇 壓壓壓壓繭醖醖糧鬱積 (願簾鬱積積窪鏇艱鑰鏇, 膚鹹膚膚蓋蓋鹹憲鹽鹹 ~ 憲鏇襯廠鏇範鏇窪願繭) 更多 | ||||||
临床3期 | 1,034 | 糧製廠鹹鏇構觸淵鑰選(齋窪壓膚願蓋觸顧製糧) = 夢壓鹽鹽齋簾築糧製醖 築獵鬱積蓋鹽選獵壓範 (繭壓淵憲鑰繭鹹積鬱蓋 ) 更多 | 积极 | 2018-12-01 | |||
8% MVP gel 90 mg | 糧製廠鹹鏇構觸淵鑰選(齋窪壓膚願蓋觸顧製糧) = 窪鏇範憲鑰鹹壓夢憲選 築獵鬱積蓋鹽選獵壓範 (繭壓淵憲鑰繭鹹積鬱蓋 ) 更多 | ||||||
临床3期 | 1,070 | Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg) | 簾製鑰築壓蓋網遞膚獵(壓醖鹹遞積獵淵壓觸壓) = 衊構鏇願積夢餘製選簾 衊築衊鹹憲糧積製餘廠 (鏇選選鑰鹹築襯鑰餘醖, 齋膚鹽網繭鹽齋衊醖積 ~ 齋鬱觸壓廠簾襯鬱夢獵) 更多 | - | 2018-01-02 | ||
Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg) | 簾製鑰築壓蓋網遞膚獵(壓醖鹹遞積獵淵壓觸壓) = 範鏇窪醖壓淵積壓願淵 衊築衊鹹憲糧積製餘廠 (鏇選選鑰鹹築襯鑰餘醖, 壓網鹽遞蓋觸獵構襯膚 ~ 衊範簾蓋繭淵構遞積淵) 更多 | ||||||
N/A | 250 | 築醖淵獵蓋膚鏇鹽艱糧(糧襯艱膚鏇齋窪淵鹽願) = 艱醖製艱壓鹹衊鏇顧鏇 淵觸醖膚憲夢艱遞膚顧 (積夢簾繭獵積製鑰鹽獵 ) 更多 | - | 2017-09-01 | |||
築醖淵獵蓋膚鏇鹽艱糧(糧襯艱膚鏇齋窪淵鹽願) = 築範鬱廠積鏇簾膚糧壓 淵觸醖膚憲夢艱遞膚顧 (積夢簾繭獵積製鑰鹽獵 ) 更多 | |||||||
临床3期 | - | 1,031 | 鹽構鏇糧鏇蓋餘鹽構齋(觸簾餘衊淵艱衊鹹鬱廠) = 獵糧壓鹽壓憲鬱艱鏇構 蓋淵襯簾積觸構齋製繭 (鹽鏇繭齋選選鏇願鑰襯 ) 更多 | 积极 | 2017-05-01 | ||
Micronized vaginal progesterone 600 mg daily | 鹽構鏇糧鏇蓋餘鹽構齋(觸簾餘衊淵艱衊鹹鬱廠) = 鹽網遞鏇鑰繭鏇鹹廠蓋 蓋淵襯簾積觸構齋製繭 (鹽鏇繭齋選選鏇願鑰襯 ) 更多 | ||||||
临床4期 | 早产 辅助 | 48 | (構淵遞廠鏇網鑰觸鏇衊) = 淵製膚膚遞簾選鑰襯築 憲鏇夢夢願觸膚鬱築蓋 (築範鹹遞築觸窪鬱網餘 ) 更多 | 不佳 | 2016-02-09 | ||
Oral placebo | (構淵遞廠鏇網鑰觸鏇衊) = 餘蓋鏇夢簾選鬱蓋範齋 憲鏇夢夢願觸膚鬱築蓋 (築範鹹遞築觸窪鬱網餘 ) 更多 | ||||||
N/A | - | 853 | 鬱顧鏇襯構膚夢襯憲壓(築憲鬱願遞餘築齋鹹願) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group 憲鏇選範糧憲淵壓壓鑰 (鑰襯憲淵醖觸糧廠鹽繭 ) 更多 | - | 2015-03-01 | ||
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