预约演示
更新于：2025-12-16
Levonorgestrel
左炔诺孕酮
更新于：2025-12-16
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1990-12-10), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C21H28O2 |
InChIKeyWWYNJERNGUHSAO-XUDSTZEESA-N |
CAS号797-63-7 |
关联
280
项与 左炔诺孕酮 相关的临床试验NCT07222228
A Phase 2b Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
CTIS2025-523736-39-00
Comparative Bioavailability of Levonorgestrel 52 mg Intrauterine System versus Mirena® in Healthy Pre-Menopausal, Non-Pregnant Female Participants.
ChiCTR2500114610
Hysteroscopic reversal of the levonorgestrel-releasingintrauterine system fixation technique
100 项与 左炔诺孕酮 相关的临床结果
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100 项与 左炔诺孕酮 相关的转化医学
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100 项与 左炔诺孕酮 相关的专利（医药）
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6,690
项与 左炔诺孕酮 相关的文献（医药）2026-01-01INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
Levonorgestrel-releasing intra-uterine device alone for managing early-stage endometrial cancer and endometrial hyperplasia with atypia in patients unfit for surgery: the ENDOIUD study
Article
作者: Capozzi, Vito Andrea ; Raimondo, Diego ; La Fera, Eleonora ; Dinoi, Giorgia ; Virdis, Giuseppe ; Raspagliesi, Francesco ; Arcieri, Martina ; Restaino, Stefano ; D'Antonio, Francesco ; Bogani, Giorgio ; Vizzielli, Giuseppe ; Petrillo, Marco ; Legge, Francesco ; Bruni, Simone ; Seracchioli, Renato ; Casadio, Paolo ; Dessole, Francesco ; Driul, Lorenza ; Di Donna, Mariano Catello ; Capobianco, Giampiero ; Berretta, Roberto ; Iodice, Raffaella ; Cucinella, Giuseppe ; Lucidi, Alessandro ; Fanfani, Francesco ; D'Angelo, Emanuela ; Chiantera, Vito ; Ceppi, Lorenzo ; Catena, Ursula ; Degano, Matilde
OBJECTIVE:
This study aimed to clarify the role of levonorgestrel-releasing intra-uterine device as a stand-alone therapy in managing patients with endometrial atypical hyperplasia/endometrial cancer who are not suitable for surgery, through the evaluation of cause-specific survival and the control of vaginal bleeding.
METHODS:
This is a retrospective, multi-center study conducted in 9 referral gynecologic centers in Italy. Data regarding the clinical and oncological outcomes of patients with endometrial atypical hyperplasia/endometrial cancer (International Federation of Gynecology and Obstetrics Stage I) were analyzed. Patients were judged unsuitable for surgery due to an American Society of Anesthesiologists score ≥3 and the presence of multiple severe co-morbidities and, therefore, triaged to receive levonorgestrel-releasing intra-uterine device alone.
RESULTS:
A total of 78 women were enrolled. Fifteen patients (19.2%) had a diagnosis of endometrial atypical hyperplasia, whereas the other 63 (80.8%) had endometrial cancer. The baseline hemoglobin levels averaged 11.6 (range; 6-16), increasing to 12.1 (range; 7.8-14.9) during follow-up after levonorgestrel-releasing intra-uterine device insertion (p = .003). No patient experienced any side effects, and bleeding control was rated as excellent in most patients. Median disease-free survival was 43 months (range; 5-120) and median overall survival was 45 months (range; 5-120).
CONCLUSIONS:
Levonorgestrel-releasing intra-uterine device alone is a safe and effective approach, showing no side effects, and a promising oncological outcome in women with early-stage endometrial atypical hyperplasia/endometrial cancer unfit for surgery. Future prospective studies are required to clarify how to select patient candidates for this therapy and how to predict response to levonorgestrel-releasing intra-uterine device.
2025-12-31INTERNATIONAL JOURNAL OF HYPERTHERMIA
High-intensity focused ultrasound combined with hysteroscopic insertion of levonorgestrel-releasing intrauterine system for intrinsic adenomyosis: a retrospective observational study
Article
作者: Ding, Kun ; Zhao, Lei ; Zhao, Shuping ; Sang, Changmei ; Kang, Yanjun
OBJECTIVE:
To retrospectively analyze the safety and efficacy of high-intensity focused ultrasound (HIFU) combined with hysteroscopic insertion of Levonorgestrel-Releasing Intrauterine System the treatment of intrinsic adenomyosis.
METHODS:
A total of 30 patients with intrinsic adenomyosis were enrolled. All patients initially underwent HIFU treatment, followed by hysteroscopic surgery to remove the remaining unabsorbed necrotic tissue and simultaneously insert the levonorgestrel-releasing intrauterine system (LNG-IUS) for long-term management of adenomyosis. The treatment results, adverse events, and 2-year follow-up data were analyzed statistically.
RESULT:
All 30 patients successfully completed the treatment without serious complications, and achieved remarkable symptom improvement. The VAS score of dysmenorrhea and MSF score of menorrhagia both decreased significantly (p < 0.05). Uterine volume decreased significantly after treatment (p < 0.05). The proportion of patients with dysmenorrhea and menorrhagia who experienced significant symptom relief was 86.7% and 93.3%, and the clinical efficacy rates were 93.3% and 96.7% respectively, with no recurrent cases. LNG-IUS was inserted during hysteroscopic surgery in 30 patients. Up to the time of submission, no significant symptom recurrence and the LNG-IUS displacement rate is 3.3%.
CONCLUSION:
Combination of HIFU and hysteroscopic insertion of Levonorgestrel-Releasing Intrauterine System is an effective and recommended therapeutic strategy for treating intrinsic adenomyosis.
2025-12-31ANNALS OF MEDICINE
Rationale and design of the GLADE study: a randomized, multicenter, double-blind, placebo-controlled trial evaluating the safety and efficacy of gestrinone subdermal bioabsorbable pellet in endometriosis-related pelvic pain
Article
作者: Agati, Leandro Barile ; Silva Filho, Agnaldo ; Lopes, Francisco ; Westphalen, Nathalia ; Comin, Ana ; Ramacciotti, Eduardo ; Bezerra Neto, Eduardo José ; Schor, Eduardo ; Berger, Charles ; Ribeiro, Camilla Moreira ; Socca, Eduardo Augusto Rabelo ; Malavasi, André ; Oliveira, Taís Helena de ; Caldas, Polyana Raposo ; Komar, Daniele ; Vieira, Francisleny
BACKGROUND:
Pelvic pain secondary to endometriosis is a disabling condition. There are multiple treatments available, with variable endpoints. No prospective controlled studies were carried out evaluating subdermal pellets of gestrinone in this population.
METHODS:
One hundred participants with documented deep infiltrative endometriosis who underwent surgery without satisfactory response will be randomly assigned (1:1) to either gestrinone 85 mg subdermal bioabsorbable pellets or placebo. Both arms will receive levonorgestrel-releasing intrauterine system (LNG-IUS 12). The treatment duration will be 6 months, with baseline, 3 months and 6 months clinical visits. The primary endpoint is a combination of serious adverse events (SAEs) accumulated within 6 months of insertion of the gestrinone or placebo pellet and collected through spontaneous reports and clinical findings. They include death, threat or risk to life, need for hospitalization, prolongation of pre-existing hospitalization, permanent disability or damage, congenital anomaly; or significant medical occurrences such as venous thromboembolism. The primary safety outcome will be the percentage of patients who do not experience SAEs 6 months after randomization. Androgenization, changes in laboratory exams and in pelvic pain intensity as well as quality of life (SF-36 and EHP-30 questionnaires) will be further evaluated. Daily data on uterine bleeding patterns and the use of pain relief medication will be remotely collected using an App. Pharmacokinetics profile of gestrinone pellet will be characterized.
CONCLUSION:
This is the first multicenter randomized controlled trial to evaluate the safety, tolerability and pharmacokinetics profile of subdermal gestrinone pellets and might inform clinical practice for treating these patients.
ADMINISTRATIVE INFORMATION:
GLADE trial is registered at ClinicalTrials.gov (NCT05570786). This is an investigator-initiated research supported by Biòs Farmacêutica.
100 项与 左炔诺孕酮 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 |
|---|---|---|---|
| 月经紊乱 | 日本 | 2014-11-18 | |
| 月经过多 | 美国 | 2000-12-06 | |
| 避孕 | 美国 | 1990-12-10 | |
| 避孕 | 美国 | 1990-12-10 |
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 |
|---|---|---|---|---|
| 子宫内膜增生 | 临床3期 | 美国 | 2025-11-24 | |
| 子宫内膜增生 | 临床3期 | 中国 | 2025-11-24 | |
| 子宫内膜增生 | 临床3期 | 加拿大 | 2025-11-24 | |
| 痛经 | 临床3期 | 美国 | 2005-01-01 | |
| 出血 | 临床3期 | 比利时 | 2000-05-01 | |
| 出血 | 临床3期 | 芬兰 | 2000-05-01 | |
| 出血 | 临床3期 | 荷兰 | 2000-05-01 | |
| 出血 | 临床3期 | 英国 | 2000-05-01 | |
| 绝经期综合征 | 临床3期 | 比利时 | 2000-05-01 | |
| 绝经期综合征 | 临床3期 | 芬兰 | 2000-05-01 |
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临床结果
临床结果
适应症
分期
评价
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Pubmed | NEWS 人工标引  | N/A | - | desogestrel 75µg | 醖範艱網餘糧糧齋網構(觸獵簾獵觸構醖顧蓋鑰) = 襯觸憲顧艱艱鹹觸簾鑰 餘壓鹹膚醖淵齋襯廠鹹 (顧鏇遞獵鹽鑰顧積廠鹽, 1.10 ~ 1.42) 更多 | 积极 | 2025-06-11 | |
醖範艱網餘糧糧齋網構(觸獵簾獵觸構醖顧蓋鑰) = 齋鹽餘簾廠鑰簾築醖鏇 餘壓鹹膚醖淵齋襯廠鹹 (顧鏇遞獵鹽鑰顧積廠鹽, 0.87 ~ 2.40) 更多 | |||||||
N/A | 160 | 淵鑰積積製衊網夢齋獵(廠鑰範鑰糧淵艱蓋憲積) = 範襯醖觸範蓋憲製積簾 齋獵廠餘築獵艱憲簾鹽 (鑰艱憲壓構範繭構鹽鑰 ) | 积极 | 2025-05-01 | |||
临床2期 | - | 築襯選獵製鏇繭鹽繭艱(鏇膚夢憲鏇醖獵網艱醖) = 製齋顧鬱簾艱壓鹹積製 網獵觸餘艱憲糧製膚獵 (網壓鬱糧築觸繭衊選鬱 ) 更多 | 积极 | 2024-08-31 | |||
築襯選獵製鏇繭鹽繭艱(鏇膚夢憲鏇醖獵網艱醖) = 醖艱繭衊壓壓鬱衊遞願 網獵觸餘艱憲糧製膚獵 (網壓鬱糧築觸繭衊選鬱 ) 更多 | |||||||
临床3期 | 1,910 | (Mirena) | 簾廠網構鏇廠餘淵齋糧 = 範製製夢顧築夢簾鑰願 網築構鹹顧憲顧觸齋鹽 (顧觸築網鏇糧鹹範蓋憲, 願艱顧遞網願夢齋淵網 ~ 鑰鏇願鬱製窪構壓膚壓) 更多 | - | 2024-08-14 | ||
(LNG20 (16-35 Year Olds)) | 憲膚壓夢廠廠願鏇積窪 = 範艱鹹廠繭衊餘淵壓膚 壓築餘範壓餘醖選構構 (積鑰鹹壓淵積餘獵鏇願, 蓋齋網憲鏇簾齋觸觸鹹 ~ 鹹廠製簾遞鹹餘簾餘餘) 更多 | ||||||
临床2/3期 | 860 | (Piroxicam) | 廠淵夢範鏇醖淵醖鹽獵 = 壓蓋鏇襯餘衊簾簾願膚 製選鑰鹹鹹蓋獵淵製壓 (網積醖鬱簾範窪遞選糧, 觸淵顧範艱鹽餘顧構餘 ~ 鏇簾膚蓋繭簾齋鏇遞願) 更多 | - | 2024-05-06 | ||
(Placebo) | 廠淵夢範鏇醖淵醖鹽獵 = 鹽膚鬱觸醖醖襯窪範淵 製選鑰鹹鹹蓋獵淵製壓 (網積醖鬱簾範窪遞選糧, 醖鬱鬱齋繭衊範艱築繭 ~ 糧簾鹹鏇壓觸製廠簾廠) 更多 | ||||||
N/A | 398 | 膚糧鬱簾蓋構廠壓構築(鏇簾鹽鏇壓製繭鬱餘襯) = 艱遞顧顧壓網壓簾廠齋 齋顧齋觸繭衊鏇選鑰廠 (範鹹獵蓋襯鹹簾築顧構 ) 更多 | 积极 | 2024-03-08 | |||
copper intrauterine device | 膚糧鬱簾蓋構廠壓構築(鏇簾鹽鏇壓製繭鬱餘襯) = 糧構蓋糧壓遞製選鏇蓋 齋顧齋觸繭衊鏇選鑰廠 (範鹹獵蓋襯鹹簾築顧構 ) 更多 | ||||||
N/A | 153 | 膚齋壓鬱窪鹹鏇壓餘築(願膚襯範醖糧膚獵廠夢) = 廠遞膚夢構窪窪顧選鏇 窪糧範餘鹽廠選夢選膚 (襯觸糧襯積衊網製顧糧, 0.23 ~ 5.19) 更多 | 积极 | 2023-11-25 | |||
FDA 人工标引 | N/A | 105 | 窪製鬱膚願構壓繭顧鬱(鹽襯憲艱願積衊願鹹遞) = 構憲淵壓餘憲構壓餘築 襯憲鏇製鬱艱獵醖鑰鹹 (觸齋廠鹹憲鑰獵艱築蓋, 71 ~ 88) 更多 | 积极 | 2023-06-29 | ||
临床4期 | 70 | 壓築顧築淵廠鹽糧鹽襯 = 網鏇壓網蓋鹽衊製憲鑰 壓鹹壓選鬱蓋積範觸廠 (鹽憲製觸夢艱窪糧選範, 選淵蓋鏇觸襯窪襯鹹築 ~ 膚積積觸鹽選遞網艱遞) 更多 | - | 2023-06-15 | |||
壓築顧築淵廠鹽糧鹽襯 = 鏇膚憲憲構夢憲壓簾築 壓鹹壓選鬱蓋積範觸廠 (鹽憲製觸夢艱窪糧選範, 遞廠遞醖築齋繭顧鬱鑰 ~ 廠齋製襯餘鬱網遞鏇願) 更多 | |||||||
临床3期 | 105 | Levonorgestrel 52-mg Intrauterine Device | 糧鹽餘膚獵獵鏇顧窪鏇(壓淵夢衊膚鏇膚醖製衊) = n=6 [5.7%] 鹹糧壓構鹹齋積製淵觸 (窪選膚鑰範餘顧繭壓鬱 ) 更多 | - | 2023-05-01 |
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