预约演示
更新于：2025-05-15
Dienogest
地诺孕素
更新于：2025-05-15
概要
基本信息
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 德国 (1991-12-11), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C20H25NO2 |
InChIKeyAZFLJNIPTRTECV-FUMNGEBKSA-N |
CAS号65928-58-7 |
Sequence Code 27661
关联
107
项与 地诺孕素 相关的临床试验ChiCTR2500101137
A Single-Center, Double-Arm, Randomized Controlled Clinical Study on the Treatment of Adenomyosis with Dienogest Combined with Magnetic Resonance-Guided Focused Ultrasound Ablation
NCT06719934
Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
IRCT20240908062973N1
Determining the therapeutic effect of letrozole and dienogest on the amount of bleeding and pain caused by adenomyosis
100 项与 地诺孕素 相关的临床结果
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100 项与 地诺孕素 相关的转化医学
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100 项与 地诺孕素 相关的专利（医药）
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1,026
项与 地诺孕素 相关的文献（医药）2025-12-31GYNECOLOGICAL ENDOCRINOLOGY
Effect over coagulation and fibrinolysis parameters of a prolonged release 24 + 4 daily use regime contraceptive formulation containing 2 mg dienogest/0.02 mg ethinylestradiol
Article
作者: Regidor, Pedro-Antonio ; Angulo, Alicyoy ; Colli, Enrico
BACKGROUND:
A prolonged release combined oral contraceptive (COC) pill, containing 2 mg dienogest (DNG)/0.02 mg ethinylestradiol (EE) in a 24 + 4 daily dosing regimen has recently been approved in Europe.
OBJECTIVE:
To determine if this COC impacts coagulation and fibrinolytic factors in comparison to an immediate release COC containing 3 mg drospirenone (DRSP)/0.02 mg EE.
METHOD:
Forty-four patients received the novel product, and forty-seven the comparator (immediate release formulation) during nine complete cycles. Coagulation and fibrinolytic parameters were evaluated: activated protein C resistance ratio, Antithrombin III (AT III), C-reactive protein, Factor VII, Factor VIII, and D-Dimer.
RESULTS:
Compared to baseline, at the end of the study both groups displayed significantly higher mean values for AT III: 1.06 mg/mL (standard deviation [SD], 95% CI, 0.98-1.15) for the DNG/EE formulation and 1.04 mg/mL (SD 95% CI, 0.96-1.12) for the comparator (p = 0.0006 and p = 0.0009, respectively). D-dimer showed a non-significant slight reduction in the DNG/EE group, from 276.62 ng/mL (SD, 95% CI, 228.92-334.26) before treatment to 243.98 ng/mL (SD, 95% CI, 192.45-309.31) ng/mL after treatment. Contrarily, the comparator displayed a non-significant rise in D-dimer values from 246.46 ng/mL (SD, 95% CI, 205.44-295.66) ng/mL to 275.30 ng/mL (SD, 95% CI 219.21-345.75; p = 0.4520). All other parameters showed no significant differences before and after the treatment for both groups.
CONCLUSION:
The COC 2 mg DNG/0.02 mg EE was not associated with any meaningful changes in the analyzed coagulation and fibrinolytic parameters indicating that a prolonged release formulation does not impact on these factors.
CLINICAL TRIAL REGISTRY:
EudraCT: 2019-0018-77-97.
2025-06-01Journal of Gynecology Obstetrics and Human Reproduction
Fertility preservation in women with endometriosis: A retrospective non-Inferiority study comparing Dienogest in the PPOS protocol to antagonist and agonist protocols
Article
作者: Ranisavljevic, Noémie ; Petit, Emmanuelle ; Lesourd, Florence ; Calero, Maureen ; Chevalier, Nicolas ; Robert, Julien ; Montagut, Marie ; Huberlant, Stéphanie
BACKGROUND:
Endometriosis is a common pathology that can lead to a decrease in fertility and is therefore a medical indication for preserving fertility. Traditionally, gonadotropin-releasing hormone (GnRH) antagonist and agonist protocols are used to stimulate the ovaries. However, the recent introduction of the progestin-primed ovarian stimulation (PPOS) protocol, using progestins to prevent LH surges, offers a new alternative. Dienogest, a progestin commonly used to treat endometriosis, could be incorporated into the PPOS protocol for patients with endometriosis, allowing them to maintain their background therapy during ovarian stimulation. The aim of this study was to assess the non-inferiority of using Dienogest in the PPOS protocol compared to antagonist and agonist protocols in terms of the number of mature oocytes retrieved from patients with endometriosis undergoing fertility preservation (FP).
METHODS:
This retrospective, multicenter, non-inferiority study was conducted in patients with endometriosis, comparing the PPOS protocol with Dienogest, the antagonist protocol, and the agonist protocol. The primary endpoint was the number of mature oocytes retrieved. The secondary endpoint included ovarian response parameters, treatment complications, and tolerance assessed by validated questionnaires.
RESULTS:
The study included 201 cycles performed in 130 patients. Non-inferiority of the PPOS-Dienogest protocol was demonstrated in pairwise comparisons against antagonist protocol (p = 0.0062) and agonist protocol (p = 0.0360) in the number of mature oocytes retrieved. Using Dienogest in the PPOS protocol was not associated with a smaller number of mature oocytes retrieved than with the GnRH antagonist or agonist conventional protocols. Additionally, no significant differences were found in ovarian response parameters, treatment tolerance, or complications between protocols.
CONCLUSION:
The PPOS protocol with Dienogest appears to be a promising alternative for FP compared to traditional protocols for patients with endometriosis, without adversely affecting the number of mature oocytes retrieved. Larger prospective studies are required to confirm these results.
2025-06-01PHYTOMEDICINE
Add-on effect of curcumin to dienogest in patients with endometriosis: a randomized, double-blind, controlled trial
Article
作者: Ghaznavi, Habib ; Sepidarkish, Mahdi ; Razavi, Maryam ; Sheervalilou, Roghayeh ; Sargazi-Taghazi, Mahjoob
BACKGROUND:
Endometriosis is a chronic gynecological disorder characterized by significant pain and reduced quality of life (QOL). Current treatments, such as dienogest, are not fully effective, prompting the investigation of curcumin as a potential adjunct therapy. Although curcumin has demonstrated promise in preclinical studies, its clinical efficacy in endometriosis, particularly in combination with standard therapies like dienogest, remains underexplored.
PURPOSE:
This is the first study aimed to evaluate the add-on effect of curcumin in combination with dienogest on pain relief, QOL, and sexual function in women with endometriosis.
STUDY DESIGN:
A randomized, double-blind, placebo-controlled trial was conducted to compare the efficacy of curcumin combined with dienogest versus dienogest alone with a placebo.
METHODS:
Eighty-six women aged 18-45 with stage 2-3 pelvic endometriosis and moderate to severe pain (visual analogue scale (VAS) ≥ 4) were randomly assigned in a 1:1 ratio to receive either nanocurcumin soft gel capsules (80 mg/day) or a placebo, along with dienogest (2 mg/day), for 8 weeks. Outcomes were assessed using adjusted mean differences (aMD) and 95 % confidence intervals (CIs).
RESULTS:
After 8 weeks, the curcumin and dienogest group demonstrated significantly greater improvements in pain scores compared to the placebo group: dysmenorrhea (aMD: -1.55, 95 %CI: -2.04 to -1.06; p < 0.001), dyspareunia (aMD: -0.93, 95 %CI: -1.37 to -0.49; p < 0.001), chronic pelvic pain (aMD: -1.55, 95 %CI: -2.04 to -1.06; p < 0.001), and dyschezia (aMD: -0.30, 95 %CI: -0.58 to -0.03; p = 0.030). Additional benefits were observed in QOL and Female Sexual Function Index (FSFI) scores, except for the orgasm domain. Differences in endometrioma size were not statistically significant.
CONCLUSION:
The combination of curcumin and dienogest significantly reduced pain and improved QOL and sexual function in women with endometriosis, suggesting curcumin as an effective adjunct therapy.
100 项与 地诺孕素 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 痛经 | 日本 | 2020-01-23 | |
| 子宫腺肌病 | 日本 | 2016-12-02 | |
| 子宫内膜异位症 | 日本 | 2007-10-19 | |
| 更年期综合症 | 德国 | 1995-05-31 | |
| 怀孕 | 德国 | 1991-12-11 |
未上市
10 条进展最快的记录, 后查看更多信息
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临床结果
临床结果
适应症
分期
评价
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N/A | 887 | Dienogest therapy | 醖願築糧衊蓋願遞繭糧(鏇艱鹽淵選蓋襯鏇簾觸) = 淵廠鏇廠願齋鹽廠鑰顧 夢鬱醖齋壓膚構衊齋夢 (齋築窪選壓製壓網獵窪 ) | 积极 | 2022-02-02 | ||
N/A | 134 | (Group A) | 鹽齋積餘蓋廠蓋憲窪齋(廠獵鏇壓餘壓窪簾鑰鬱) = 淵齋壓構鑰願憲範築鹹 範淵壓膚積願壓壓鹽夢 (齋構觸廠顧壓餘齋夢夢 ) 更多 | 积极 | 2021-03-30 | ||
(Group B) | 鹽齋積餘蓋廠蓋憲窪齋(廠獵鏇壓餘壓窪簾鑰鬱) = 製顧製壓鏇醖鹽簾鹽齋 範淵壓膚積願壓壓鹽夢 (齋構觸廠顧壓餘齋夢夢 ) 更多 | ||||||
临床3期 | 220 | 糧壓顧鏇壓糧獵鬱鹹廠(夢繭廠網顧網壓獵淵衊) = 範範憲餘膚構衊願廠構 衊糧網顧蓋餘繭艱鑰夢 (糧顧鑰壓鹹積簾醖廠糧, 26.54) | 积极 | 2019-02-01 | |||
Placebo | 糧壓顧鏇壓糧獵鬱鹹廠(夢繭廠網顧網壓獵淵衊) = 膚醖鹹築艱選觸鹽鏇糧 衊糧網顧蓋餘繭艱鑰夢 (糧顧鑰壓鹹積簾醖廠糧, 31.15) | ||||||
临床3期 | 190 | (Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)) | 餘糧齋廠壓壓襯廠顧齋 = 蓋齋觸顧蓋齋鏇範積築 齋夢鏇鹽積鹽糧憲膚窪 (餘膚選顧膚鏇鑰鏇觸鏇, 鏇製廠鑰築醖簾簾鏇蓋 ~ 鹹製鑰衊鹽憲選網襯鬱) 更多 | - | 2011-06-06 | ||
Placebo (Placebo) | 餘糧齋廠壓壓襯廠顧齋 = 壓艱繭遞艱糧鹹餘觸膚 齋夢鏇鹽積鹽糧憲膚窪 (餘膚選顧膚鏇鑰鏇觸鏇, 艱壓簾壓遞繭鑰觸蓋夢 ~ 網遞製獵鏇觸壓鑰鏇遞) 更多 |
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