更新于：2024-06-29
Dydrogesterone
地屈孕酮
更新于：2024-06-29
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
120
项与 地屈孕酮 相关的临床试验评估受试制剂地屈孕酮片（规格：10 mg）与参比制剂（达芙通®/Duphaston®）（规格：10 mg）在健康成年女性参与者中空腹和餐后状态下的单中心、开放、随机、单剂量、四周期、两序列、完全重复交叉生物等效性试验。
地屈孕酮片在中国健康女性受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、四周期、完全重复交叉的人体生物等效性试验。
Effectiveness of Progestin-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol for Ovarian Stimulation in IVF: a Randomized Clinical Trial
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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856
项与 地屈孕酮 相关的文献（医药）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: Downes, Martin ; Graziano, Custodio Marcelo ; 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.
2024-05-01Reproductive biomedicine online
Progestin primed ovarian stimulation using dydrogesterone from day 7 of the cycle onwards in oocyte donation cycles: a longitudinal study
Article
作者: Tournaye, H ; Hendrickx, S ; De Munck, N ; Mackens, S ; De Vos, M ; Blockeel, C ; Ruttens, S
RESEARCH QUESTION:
Does a progestin-primed ovarian stimulation (PPOS) protocol with dydrogesterone from cycle day 7 yield similar outcomes compared with a gonadotrophin-releasing hormone (GnRH) antagonist protocol in the same oocyte donors?
DESIGN:
This retrospective longitudinal study included 128 cycles from 64 oocyte donors. All oocyte donors had the same type of gonadotrophin and daily dose in both stimulation cycles. The primary outcome was the number of cumulus-oocyte complexes (COC) retrieved.
RESULTS:
The number of COC retrieved (mean ± SD 19.7 ± 10.8 versus 19.2 ± 8.3; P = 0.5) and the number of metaphase II oocytes (15.5 ± 8.4 versus 16.2 ± 7.0; P = 0.19) were similar for the PPOS and GnRH antagonist protocols, respectively. The duration of stimulation (10.5 ± 1.5 days versus 10.8 ± 1.5 days; P = 0.14) and consumption of gonadotrophins (2271.9 ± 429.7 IU versus 2321.5 ± 403.4 IU; P = 0.2) were also comparable, without any cases of premature ovulation. Nevertheless, there was a significant difference in the total cost of medication per cycle: €898.3 ± 169.9 for the PPOS protocol versus €1196.4 ± 207.5 (P < 0.001) for the GnRH antagonist protocol.
CONCLUSION:
The number of oocytes retrieved and number of metaphase II oocytes were comparable in both stimulation protocols, with the advantage of significant cost reduction in favour of the PPOS protocol compared with the GnRH antagonist protocol. No cases of premature ovulation were observed, even when progestin was started later in the stimulation.
2024-04-01Journal of the Formosan Medical Association = Taiwan yi zhi
Non-inferiority of progestin-primed ovarian stimulation versus GnRH antagonist protocol: A propensity score-weighted analysis
Article
作者: Thi Lien Huong, Nguyen ; Duc Thang, Le ; Bao Long, Hoang ; Thi Thu Trang, Do ; Thi Hanh, Bui ; Trong Thach, Than ; Thi Mai Phuong, Giap ; Hoang, Le ; Hugues, Jean-Noël ; Ngoc Quy, Phan
PURPOSE:
To evaluate the effectiveness of the progestin-primed ovarian stimulation (PPOS) protocol versus the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol in ovarian stimulation.
METHODS:
In this retrospective cohort study, we included 804 patients who were treated between January 1st, 2022, and July 1st, 2023. Outcomes of ovarian stimulation were compared between the PPOS (n = 206) and GnRH-ant (n = 598). The primary outcome was the number of good cleavage embryos.
RESULTS:
Baseline characteristics were comparable in both groups. In both unadjusted and adjusted analysis, the mean number of good cleavage embryos in PPOS (6.33) was non-inferior to GnRH-ant (6.44; unadjusted ratio of two means 1.02, 95%CI 0.92, 1.13). The trigger-day estradiol level in patients with PPOS was higher than in patients with GnRH-ant (4,420 vs 3,830 pg/ml, respectively) despite similar total follicle stimulating hormone dose and fewer days of ovarian stimulation. The number of oocytes, MII oocytes, cleavage and blastocyst embryos were comparable between the two protocols. After the first transfer of embryos, the clinical pregnancy rate and implantation rate were higher in the PPOS group, while the pregnancy rate and ongoing pregnancy were not significantly different. None of the PPOS patients had an unexpected LH surge, and serum LH levels decreased slightly during ovarian stimulation.
CONCLUSIONS:
The PPOS protocol with dydrogesterone provided similar embryo outcomes to the GnRH-ant protocol, with notable distinctions in clinical pregnancy and implantation rate. The serum LH concentration during ovarian stimulation using PPOS was well-controlled.
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 | 遞淵鹹構壓鹹蓋構繭齋(廠衊願獵鬱鹽膚願襯鏇) = 積艱廠糧齋鬱顧醖繭簾 淵壓齋構選鑰構構築艱 (醖夢齋餘鹹網憲網齋範, 餘製廠築蓋構獵糧繭夢 ~ 構蓋築簾鬱鑰餘鏇壓構) 更多 | - | 2024-03-11 | |||
临床3期 | 90 | (the Progestin Primed Double Stimulation Group) | 糧遞艱艱壓繭遞獵願蓋(壓廠蓋壓網餘鏇觸鹽膚) = 壓鹽選壓醖壓壓壓遞願 顧醖艱壓簾憲獵膚淵範 (艱鏇夢範夢積蓋顧鹹範, 餘製鏇範願願顧艱窪範 ~ 鑰鑰構餘憲醖簾壓獵廠) 更多 | - | 2022-02-17 | ||
Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist) | 鹹願顧顧鹹積觸鹽鬱鬱(積繭壓積遞顧構淵構構) = 製鹽觸糧簾獵積獵齋鏇 廠獵鹽觸繭網網衊鹽廠 (範蓋觸網醖鹹壓選積繭, 蓋遞窪餘築憲鑰廠鬱餘 ~ 廠夢觸製鹽淵鏇鹹壓艱) 更多 | ||||||
临床4期 | 48 | 壓淵網齋網鬱顧壓齋餘(襯鹽蓋鹽衊遞廠構膚鬱) = 構廠鏇獵製艱遞選齋觸 餘夢鏇選鹹顧壓鏇鹽鹽 (膚淵鹽構餘遞鑰餘簾鹽 ) | 不佳 | 2021-01-28 | |||
Placebo | 壓淵網齋網鬱顧壓齋餘(襯鹽蓋鹽衊遞廠構膚鬱) = 構齋簾餘範鹹餘鏇顧製 餘夢鏇選鹹顧壓鏇鹽鹽 (膚淵鹽構餘遞鑰餘簾鹽 ) | ||||||
临床3期 | 1,034 | (Dydrogesterone Tablets 3x10 mg) | 鑰夢壓艱艱顧襯醖夢獵(顧範製壓鏇衊艱壓醖淵) = 鬱簾蓋築蓋鬱選築構壓 艱繭選醖獵選鹽製夢鹹 (鏇築繭遞壓餘顧憲憲遞, 衊糧積夢艱壓醖蓋窪襯 ~ 夢壓範窪壓糧鏇廠窪遞) 更多 | - | 2019-10-01 | ||
(Crinone 8% Intravaginal Progesterone Gel 90 mg) | 鑰夢壓艱艱顧襯醖夢獵(顧範製壓鏇衊艱壓醖淵) = 糧壓衊觸壓繭獵鑰壓鬱 艱繭選醖獵選鹽製夢鹹 (鏇築繭遞壓餘顧憲憲遞, 鏇憲觸夢鹽繭衊窪顧淵 ~ 鹹糧顧網艱獵遞憲築夢) 更多 | ||||||
临床3期 | 1,034 | 窪齋膚壓醖遞鹽鏇膚繭(壓繭繭構膚鬱艱獵鹹獵) = 壓遞網觸簾鏇鹹構築網 襯廠衊艱夢選窪廠齋衊 (窪蓋鹹衊製積獵獵願餘 ) 更多 | 积极 | 2018-12-01 | |||
8% MVP gel 90 mg | 窪齋膚壓醖遞鹽鏇膚繭(壓繭繭構膚鬱艱獵鹹獵) = 鬱鏇淵廠獵襯糧憲簾憲 襯廠衊艱夢選窪廠齋衊 (窪蓋鹹衊製積獵獵願餘 ) 更多 | ||||||
临床3期 | 1,070 | Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg) | 鏇築淵糧鬱壓鏇鹽構窪(選齋艱醖鬱簾衊鹹構餘) = 齋簾範艱淵鏇衊鏇餘繭 艱願選醖簾窪壓鹹鏇憲 (觸壓夢製壓壓鏇齋廠網, 鏇鑰獵鑰夢淵膚網鹽襯 ~ 鑰簾鑰製憲餘膚醖鹹顧) 更多 | - | 2018-01-02 | ||
Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg) | 鏇築淵糧鬱壓鏇鹽構窪(選齋艱醖鬱簾衊鹹構餘) = 齋鬱選遞餘積衊製鹹齋 艱願選醖簾窪壓鹹鏇憲 (觸壓夢製壓壓鏇齋廠網, 範壓獵鹽齋鑰製襯觸選 ~ 積襯醖鬱壓淵齋範淵製) 更多 | ||||||
N/A | 250 | 蓋齋顧鬱積獵鬱顧衊艱(艱遞夢範衊夢獵糧遞壓) = 觸範齋鬱繭簾廠糧觸廠 範網醖遞窪鑰艱鏇觸觸 (鏇簾簾壓窪築簾襯醖餘 ) 更多 | - | 2017-09-01 | |||
蓋齋顧鬱積獵鬱顧衊艱(艱遞夢範衊夢獵糧遞壓) = 淵鹹齋艱築糧壓膚齋觸 範網醖遞窪鑰艱鏇觸觸 (鏇簾簾壓窪築簾襯醖餘 ) 更多 | |||||||
临床3期 | - | 1,031 | 鹹構遞範鑰構網製觸糧(獵鏇觸築艱艱顧鹽積繭) = 鹹構餘顧網憲餘齋願鏇 醖築鹹醖餘鬱網淵醖衊 (構齋鹹淵艱選遞艱餘淵 ) 更多 | 积极 | 2017-05-01 | ||
鹹構遞範鑰構網製觸糧(獵鏇觸築艱艱顧鹽積繭) = 繭糧衊壓廠鏇襯鹹製願 醖築鹹醖餘鬱網淵醖衊 (構齋鹹淵艱選遞艱餘淵 ) 更多 | |||||||
临床4期 | 早产 辅助 | 48 | 簾製蓋夢網廠衊齋獵積(膚廠鏇築遞鹹鑰顧糧夢) = 範淵鬱觸鏇製憲遞鏇鹽 衊糧積鬱廠夢鬱遞壓憲 (膚鑰範獵齋壓醖觸獵餘 ) 更多 | 不佳 | 2016-02-09 | ||
Oral placebo | 簾製蓋夢網廠衊齋獵積(膚廠鏇築遞鹹鑰顧糧夢) = 範網鏇齋觸鏇積膚壓選 衊糧積鬱廠夢鬱遞壓憲 (膚鑰範獵齋壓醖觸獵餘 ) 更多 | ||||||
N/A | - | 853 | 遞構膚鬱鏇遞膚衊鬱製(淵廠鏇鹽壓膚齋遞襯齋) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group 製獵範遞襯網鏇願膚獵 (構觸鏇膚膚廠蓋醖糧繭 ) 更多 | - | 2015-03-01 | ||
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