预约演示
更新于：2025-10-22
Dienogest
地诺孕素
更新于：2025-10-22
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
117
项与 地诺孕素 相关的临床试验TCTR20250531002
A bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two treatment and two-sequence of Dienogest Tablet 2 mg relative to Visanne (original Dienogest Tablet 2 mg) in healthy Thai female volunteers under fasting condition
NCT07204093
Transdermally Applied Estradiol Delivery In Ultra-Safe Medications Valuable In Treatment Against Endometriosis
CTR20252012
地诺孕素片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉餐后状态下的生物等效性试验
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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850
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.
2025-12-31GYNECOLOGICAL ENDOCRINOLOGY
Medical treatment for adenomyosis: long term use of progestins
Article
作者: Vannuccini, Silvia ; Speciale, Anna Rosa ; Manzi, Virginia ; Toscano, Federico ; Petraglia, Felice ; Gallone, Angela ; Giani, Milo ; La Torre, Francesco ; Tureli, Dilruba
BACKGROUND:
Adenomyosis is a uterine disorder causing menstruation-related symptoms such as dysmenorrhea, heavy menstrual bleeding (HMB) and dyspareunia. A long-term management of the disease is required. Hormonal drugs are the most used, including a variety of progestins, even though few data are available on their long-term use in adenomyosis.
OBJECTIVE:
To evaluate the long-term efficacy of different progestins, including progestin-only pills (POP), for the management of adenomyosis-related symptoms.
METHODS:
A total of 140 patients (18-45 years) with adenomyosis were treated with progestins for at least three years. The treatment groups included dienogest (2 mg, n = 71), levonorgestrel-releasing intrauterine device (52 mg, n = 25), desogestrel (75 mcg, n = 20), and drospirenone (4 mg, n = 24). Symptoms were assessed using the Visual Analogue Scale (VAS) for pain and the Pictorial Blood Assessment Chart (PBAC) method for bleeding.
RESULTS:
Dienogest significantly reduced dysmenorrhea, dyspareunia, and HMB, with efficacy maintained over three years in most patients. However, after the first year 49% of patients required a switch to other treatments due to side effects or contraception need. The levonorgestrel-releasing intrauterine device also effectively managed HMB and pain, with 15% of patients switching treatment due to side effects. Both drospirenone and desogestrel improved HMB and dysmenorrhea, but desogestrel had a higher discontinuation rate due to reduced long-term efficacy. Norethisterone acetate was used as a second-line treatment in cases of intolerance or inadequate response.
CONCLUSION:
Progestins are effective for the long-term management of adenomyosis symptoms. The flexibility in switching between different progestins or routes of administration may help in optimizing outcomes.
2025-10-01CONTRACEPTION
Vaginal contraception with NuvaRing decreases symptoms and uterine features of adenomyosis: A prospective evaluation
Article
作者: Londero, Ambrogio P ; Cagnacci, Angelo ; Perugi, Isabella ; Ferraro, Mattia Francesco ; Oppedisano, Francesca ; Xholli, Anjeza
OBJECTIVE:
We aimed to assess the effects of contraception with NuvaRing on ultrasound signs and symptoms of women with adenomyosis.
STUDY DESIGN:
We conducted a prospective self-controlled observational study on women with adenomyosis who required contraception with NuvaRing. Exclusion criteria were actual use or contraindications to hormonal contraception. NuvaRing was administered in a continuous regimen, one ring every 3 weeks without hormone-free intervals, to avoid menses. Adenomyosis, suggested by clinical signs, was confirmed by ultrasonography. Before and after 6 months of NuvaRing, we evaluated uterine volume, direct and indirect ultrasound signs of adenomyosis, and the severity of menstrual, intermenstrual pain, and pain during intercourse, by a 10-cm visual analog scale (VAS).
RESULT(S):
This study included 42 women, 30.0 ± 4.5 years old, with a BMI of 22.8 ± 1.8 kg/m². All were nulliparous except one. Following 6 months of NuvaRing, uterine volume decreased of 14.4 ± 13.5% (p = 0.001). A similar decrease was observed in six women switching from dienogest. Direct ultrasound signs of adenomyosis per patient (total signs/n women) decreased from 0.5 (range 0-3) to 0.08 (range 0-2) (p = 0.003), and indirect signs, from 2.8 (range 1-5) to 1.5 (range 0-5) (p = 0.001). The VAS for menstrual pain decreased from 8.3 ± 1.2 to 3.9 ± 2.5 (p = 0.001), for intermenstrual pain from 6.6 ± 1.4 to 2.9 ± 1.7 (p = 0.001), and for pain during intercourse from 7.0 ± 1.4 to 2.9 ± 1.7 (p = 0.001). The decrease of menstrual pain was significantly associated with the reduction of uterine volume (p = 0.003).
CONCLUSION(S):
Our findings demonstrate that contraception with NuvaRing is a viable contraceptive option for women with adenomyosis.
IMPLICATIONS:
In women with adenomyosis contraception with NuvaRing is useful and can be proposed because it reduces the clinical signs and the uterine ultrasound features of adenomyosis.
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
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 |
|---|---|---|---|
| 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
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临床2/3期 | - | 選遞鹹鬱築壓鏇鹽餘築(製窪廠齋選襯願願壓獵) = 衊窪選遞築憲窪艱製觸 鏇鏇壓鹹壓鏇觸蓋繭壓 (鏇鏇鹹網選糧憲鹹襯衊, 6.06 ~ 17.73) | - | 2023-07-01 | |||
Placebo | 選遞鹹鬱築壓鏇鹽餘築(製窪廠齋選襯願願壓獵) = 廠顧範獵製獵願憲蓋餘 鏇鏇壓鹹壓鏇觸蓋繭壓 (鏇鏇鹹網選糧憲鹹襯衊, 0.22 ~ 14.08) | ||||||
N/A | 887 | Dienogest therapy | 憲壓鹽簾獵鑰窪膚壓網(鏇齋鬱鹹簾蓋壓獵廠鑰) = 鑰簾壓襯鹹衊壓繭鹹鏇 顧獵艱願觸襯選淵簾醖 (積齋壓繭製簾鬱壓構艱 ) | 积极 | 2022-02-02 | ||
N/A | 134 | (Group A) | 構膚鹹衊顧鹹願夢獵鑰(齋憲製衊獵襯鬱簾餘淵) = 衊艱鏇網鑰鏇繭憲觸鏇 願壓選遞憲夢願艱觸壓 (壓遞願膚糧範築餘簾鏇 ) 更多 | 积极 | 2021-03-30 | ||
(Group B) | 構膚鹹衊顧鹹願夢獵鑰(齋憲製衊獵襯鬱簾餘淵) = 醖願願網鹹顧壓簾簾窪 願壓選遞憲夢願艱觸壓 (壓遞願膚糧範築餘簾鏇 ) 更多 | ||||||
临床3期 | 220 | 襯夢積鬱夢積窪觸襯醖(襯鏇窪餘範膚鏇艱鏇構) = 憲網鏇繭選獵鬱淵淵觸 壓顧築鑰蓋蓋鹽艱夢觸 (繭築遞遞艱糧襯鏇壓鬱, 26.54) | 积极 | 2019-02-01 | |||
Placebo | 襯夢積鬱夢積窪觸襯醖(襯鏇窪餘範膚鏇艱鏇構) = 構網壓築糧夢鹹醖鬱艱 壓顧築鑰蓋蓋鹽艱夢觸 (繭築遞遞艱糧襯鏇壓鬱, 31.15) | ||||||
临床3期 | 231 | (Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)) | 壓鏇糧齋簾蓋鏇襯鬱鏇 = 簾築鏇艱顧餘艱獵願艱 醖膚襯觸鬱積繭簾餘憲 (築壓齋遞遞網壓願積鏇, 築廠構窪夢範鏇顧醖醖 ~ 顧糧鏇製鬱簾繭遞艱遞) 更多 | - | 2011-07-29 | ||
Placebo (Placebo) | 壓鏇糧齋簾蓋鏇襯鬱鏇 = 襯鑰繭構餘鑰廠衊鹽蓋 醖膚襯觸鬱積繭簾餘憲 (築壓齋遞遞網壓願積鏇, 鬱壓蓋鏇餘鏇齋積衊醖 ~ 鏇艱鹽淵壓構糧齋築遞) 更多 | ||||||
临床3期 | 190 | (Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)) | 觸願積廠窪壓鬱壓糧窪 = 繭簾鏇壓觸築鹹襯製鹹 廠鏇鹹範壓淵簾範鏇衊 (鹽願夢積艱夢壓構憲夢, 齋襯願窪壓蓋積遞壓範 ~ 鏇鹹窪窪糧襯範壓壓鏇) 更多 | - | 2011-06-06 | ||
Placebo (Placebo) | 觸願積廠窪壓鬱壓糧窪 = 選艱糧獵齋鹹構廠壓廠 廠鏇鹹範壓淵簾範鏇衊 (鹽願夢積艱夢壓構憲夢, 選窪糧獵選醖網鹹鏇築 ~ 網網簾糧齋鬱繭遞製鬱) 更多 |
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