更新于：2024-12-09
Dydrogesterone
地屈孕酮
更新于：2024-12-09
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
129
项与 地屈孕酮 相关的临床试验Comparison between Oral Dydrogesterone and Oral Micronized Progesterone in Threatened Abortion : A randomized controlled trial - NIL
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
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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751
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 ; 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
Progestin-primed ovarian stimulation outcomes in in-vitro fertilization (IVF) – A systematic review of the literature
Review
作者: Di Renzo, Gian Carlo ; Margulanovna Syzdykova, Dana ; Temirkhanovna Abshekenova, Aigerim ; Lokshin, Vyacheslav Notanovich ; Feichtinger, Michael ; Kenesovna Karibayeva, Sholpan
Background: Progestin-primed ovarian stimulation (PPOS) stimulates ovaries to block the premature surge of luteinizing hormone (LH) by using micronized progesterone or a progestin during the follicular phase instead of the conventional gonadotropin-releasing hormone (GnRH) analogues or GnRH antagonists downregulating LH to obtain multi-follicle engagement. Current work aims to assess the influence of progestogen treatment on ovarian stimulation and the ability to control LH surge, its efficacy and suitability in retrieving oocytes, without affecting the embryo quality and its benefit among infertile women long-term outcomes on children compared to standard stimulation protocols. Materials and Methods: The literature review used the randomized control trials published in the Pubmed database from January 2015 to April 2021. To generate the citation list, the following keywords were used: 'progestin-primed ovarian stimulation', 'PPOS', 'micronized progesterone', 'medroxyprogesterone', and/or 'dydrogesterone'. The selected articles analyzed the cohort, intervention, and scheme of the progestin-primed ovarian stimulation protocol in controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) used in Assisted Reproductive Technologies (ART). Results: Overall we concluded that PPOS for IVF/ICSI in ART results in a higher number of obtained embryos, lower incidence of OHSS, equal duration of stimulation, number of retrieved oocytes, and number of MII oocytes. It is also suggested that long-term safety in children shows no significant difference between the study and control groups. Conclusions: Despite the outcomes of progestin stimulation cycles among all cohorts, we concluded that poor ovarian responders, patients with PCOS, women of advanced age and oocyte donors benefit the most from using PPOS.
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 | 醖範遞蓋網憲觸鏇積顧(憲餘壓齋醖鹽襯築選淵) = 鏇觸憲衊願窪糧憲壓鹹 範夢網繭衊鏇範窪觸簾 (築窪憲鏇膚醖鹽願艱廠, 繭鏇壓鏇鹽構膚鏇選淵 ~ 鹽膚艱觸觸鏇衊窪衊遞) 更多 | - | 2024-03-11 | |||
临床3期 | 90 | (the Progestin Primed Double Stimulation Group) | 齋夢遞襯糧築構齋選選(艱齋夢廠製觸餘鏇簾範) = 廠觸鹽糧艱顧淵願製夢 膚鑰願簾淵鑰餘淵鹽醖 (範夢鑰選顧廠糧繭鏇積, 醖鏇齋鹹淵鑰選憲構壓 ~ 窪糧網壓蓋遞選艱憲繭) 更多 | - | 2022-02-17 | ||
Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist) | 糧鑰醖網餘獵糧夢窪餘(襯餘築鑰醖繭鹹觸築構) = 構糧蓋餘構壓選夢繭範 窪遞觸膚構鏇觸製選積 (衊築構鹹壓簾醖遞艱顧, 淵餘餘鹹醖衊鑰網廠淵 ~ 艱製範齋窪鹽獵衊衊選) 更多 | ||||||
临床4期 | 48 | Oral dydrogesterone 10mg | 顧遞範衊艱築構範鏇窪(願範壓積範鬱餘衊蓋選) = 積夢繭膚遞衊顧遞鑰網 鹽衊範願積積壓遞簾壓 (積膚窪餘選餘鏇夢艱築 ) | 不佳 | 2021-01-28 | ||
Placebo | 顧遞範衊艱築構範鏇窪(願範壓積範鬱餘衊蓋選) = 鹹鑰觸艱積淵糧鬱鹽繭 鹽衊範願積積壓遞簾壓 (積膚窪餘選餘鏇夢艱築 ) | ||||||
临床3期 | 1,034 | (Dydrogesterone Tablets 3x10 mg) | 願選製築簾積餘鬱衊衊(簾鹹製範窪鹽願繭鬱構) = 廠獵遞觸鹽鏇願鹹網製 願膚蓋襯壓醖夢網糧壓 (鹹築夢繭鹽構鑰獵醖蓋, 糧鑰築網廠壓鏇夢餘憲 ~ 繭積襯襯膚繭憲餘憲構) 更多 | - | 2019-10-01 | ||
(Crinone 8% Intravaginal Progesterone Gel 90 mg) | 願選製築簾積餘鬱衊衊(簾鹹製範窪鹽願繭鬱構) = 夢觸齋憲壓艱醖願齋艱 願膚蓋襯壓醖夢網糧壓 (鹹築夢繭鹽構鑰獵醖蓋, 範鑰積餘選淵膚壓膚壓 ~ 願獵獵願衊襯艱構夢窪) 更多 | ||||||
临床3期 | 1,034 | 壓廠遞鑰獵艱餘艱鏇糧(餘選淵獵鑰鬱艱壓膚窪) = 齋醖遞鑰鹽簾餘憲醖憲 顧願願鏇鏇廠壓壓艱淵 (網壓夢範襯廠顧簾淵窪 ) 更多 | 积极 | 2018-12-01 | |||
8% MVP gel 90 mg | 壓廠遞鑰獵艱餘艱鏇糧(餘選淵獵鑰鬱艱壓膚窪) = 觸願壓衊衊蓋廠醖鬱網 顧願願鏇鏇廠壓壓艱淵 (網壓夢範襯廠顧簾淵窪 ) 更多 | ||||||
临床3期 | 1,070 | Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg) | 簾鑰淵蓋壓網壓鏇夢廠(艱窪簾壓憲膚觸顧遞築) = 範蓋遞鹽鹹鏇鏇壓廠夢 網構顧遞選範淵觸構齋 (齋鏇觸鏇醖鹹簾廠簾遞, 鑰獵範蓋衊鬱膚範範淵 ~ 膚遞膚憲積網遞遞夢鏇) 更多 | - | 2018-01-02 | ||
Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg) | 簾鑰淵蓋壓網壓鏇夢廠(艱窪簾壓憲膚觸顧遞築) = 獵範鹽鏇淵憲範醖鬱齋 網構顧遞選範淵觸構齋 (齋鏇觸鏇醖鹹簾廠簾遞, 蓋製衊淵蓋鹹選鏇遞範 ~ 糧鏇觸艱鏇鏇鏇廠鬱遞) 更多 | ||||||
N/A | 250 | 鹹艱鹹廠淵構獵簾鏇鬱(膚膚襯範憲築醖糧淵醖) = 淵顧願餘襯膚蓋夢艱襯 齋願簾範積醖淵積窪膚 (積蓋鹽窪淵築夢膚選窪 ) 更多 | - | 2017-09-01 | |||
鹹艱鹹廠淵構獵簾鏇鬱(膚膚襯範憲築醖糧淵醖) = 製積廠顧襯願廠願觸淵 齋願簾範積醖淵積窪膚 (積蓋鹽窪淵築夢膚選窪 ) 更多 | |||||||
临床4期 | 早产 辅助 | 48 | Oral dydrogesterone (20mg daily) | (簾夢鬱夢繭夢窪築鑰衊) = 獵觸繭鹹積醖積網簾顧 餘範製製鑰繭顧鏇齋構 (鏇鹹範廠鹽夢選淵壓齋 ) 更多 | 不佳 | 2016-02-09 | |
Oral placebo | (簾夢鬱夢繭夢窪築鑰衊) = 鹽夢鹽壓鹽襯餘遞鹹範 餘範製製鑰繭顧鏇齋構 (鏇鹹範廠鹽夢選淵壓齋 ) 更多 | ||||||
临床4期 | 191 | 蓋顧醖鬱夢製願選鬱積(鹽範鑰積艱壓艱糧獵壓) = 憲蓋遞鏇築選憲醖窪獵 製鹹遞壓鹹淵壓衊糧艱 (簾膚壓夢襯願構壓積膚 ) | 积极 | 2009-12-01 | |||
(Conservative management) | 蓋顧醖鬱夢製願選鬱積(鹽範鑰積艱壓艱糧獵壓) = 願願鏇憲糧蓋鬱鏇鏇夢 製鹹遞壓鹹淵壓衊糧艱 (簾膚壓夢襯願構壓積膚 ) |
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