ZEG Berlin, 10115, Berlin, Germany.
Department of Reproductive Endocrinology, University Hospital Zurich, 8091, Zurich, Switzerland.
Adv Ther. 2020 May;37(5):2528-2537. doi: 10.1007/s12325-020-01331-z. Epub 2020 Apr 16.
Endometriosis is a common gynecologic disease associated with a significant burden on women's health and healthcare systems. Currently approved hormonal treatments for endometriosis can be effective in controlling symptoms, but may have clinically relevant side effects that limit their long-term use. Dienogest 2 mg (Visanne; Bayer AG, Berlin, Germany) is a 19-nortestosterone derivative that significantly reduces menstrual bleeding, dysmenorrhea, premenstrual pain, dyspareunia, and pelvic pain in women with endometriosis. Although dienogest 2 mg has demonstrated efficacy in clinical trials, data regarding long-term and real-world use are limited.
To our knowledge, the Visanne Post-approval Observational Study (VIPOS) is the largest real-world, noninterventional study performed examining the safety of dienogest and other hormonal treatments for the management of endometriosis in routine clinical practice. Patients self-reported medical and gynecologic history and symptoms and treatment information. Primary clinical outcomes were clinically validated and subject to independent blinded adjudication. Loss to follow-up was minimized through active contact with participating women at 6 months post-enrollment and annually thereafter to ensure almost all clinically relevant outcomes were captured.
VIPOS planned to enroll approximately 25,000 women initiating a new treatment for endometriosis, including those prescribed dienogest 2 mg/day and other hormonal medications for endometriosis (approved or nonapproved), from approximately 1000 centers in six European countries. The main clinical outcomes of interest for follow-up are anemia requiring medical intervention, de novo or clinically worsening depression, and treatment-failure patterns that result in drug discontinuation. Additional analyses will characterize the baseline risk factors of medically managed patients with endometriosis and assess treatment utilization patterns. VIPOS was designed to provide real-world information on endometriosis treatment and associated clinical outcomes, while not affecting the prescribing physician's decisions or the classification of patient diagnoses.
European Union Electronic Register of Post-Authorisation Studies (EU PAS) no. 1613, Clinicaltrials.gov: NCT01266421.
子宫内膜异位症是一种常见的妇科疾病，对女性健康和医疗体系造成了重大负担。目前批准用于子宫内膜异位症的激素治疗方法可以有效控制症状，但可能具有临床相关的副作用，限制了其长期使用。地诺孕素 2 毫克（唯散宁；拜耳公司，德国柏林）是一种 19-去甲睾酮衍生物，可显著减少子宫内膜异位症女性的月经出血、痛经、经前期疼痛、性交痛和盆腔痛。虽然地诺孕素 2 毫克在临床试验中已显示出疗效，但关于长期和真实世界使用的数据有限。
据我们所知，唯散宁上市后观察性研究（VIPOS）是迄今为止规模最大的真实世界、非干预性研究，旨在检查地诺孕素和其他激素治疗子宫内膜异位症的安全性，这些治疗方法在常规临床实践中的应用。患者自我报告了医疗和妇科病史以及症状和治疗信息。主要临床结局经过临床验证并接受独立盲法裁决。通过在入组后 6 个月和此后每年与参与女性进行积极联系，最大限度地减少失访，以确保几乎所有临床相关结局都被捕获。
VIPOS 计划招募约 25000 名新诊断为子宫内膜异位症的女性，包括每天服用地诺孕素 2 毫克和其他用于治疗子宫内膜异位症的激素药物（已批准或未批准）的患者，来自欧洲六个国家的约 1000 个中心。随访的主要临床结局包括需要医学干预的贫血、新发或临床恶化的抑郁以及导致药物停药的治疗失败模式。其他分析将描述接受医学治疗的子宫内膜异位症患者的基线风险因素，并评估治疗利用模式。VIPOS 的设计目的是提供关于子宫内膜异位症治疗和相关临床结局的真实世界信息，同时不影响处方医生的决策或患者诊断的分类。
欧盟药品上市后监测研究电子注册系统（EU PAS）编号 1613，临床试验.gov：NCT01266421。
