Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study

Klaas Heinemann, Bruno Imthurn, Lena Marions, Christoph Gerlinger, Kerstin Becker, Sabine Moehner, Thomas Faustmann
Advances in therapy · 2020 · vol. 37(5) , pp. 2528–2537 · doi:10.1007/s12325-020-01331-z · PMID:32301063 · PMC7467487 · W3016558605
article OA: gold CC0 ⤵ 16 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This real-world observational study is evaluating the safety of dienogest and other hormonal endometriosis treatments in approximately 25,000 women by assessing anemia, depression, and treatment discontinuation.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-07 ⓘ

This paper describes the design of VIPOS, a prospective, noninterventional, real-world active surveillance cohort enrolling about 25,000 women across ~1000 centers in six European countries who were initiating new hormonal treatments for endometriosis (including dienogest 2 mg/day and other approved or nonapproved hormonal options). The study relies on patient self-report plus clinically validated outcomes adjudicated by independent blinded reviewers, with planned follow-up and active contact to minimize loss to follow-up, and it focuses on safety endpoints such as anemia requiring medical intervention, new or worsening depression, and treatment failure patterns leading to discontinuation, alongside analyses of baseline risk factors and utilization patterns. A major caveat is that, as a noninterventional observational study, it does not control prescribing decisions or treatment allocation, even though it aims for standardized data capture and noninterference with clinicians’ behavior. This paper is centrally about endometriosis—specifically, the real-world safety monitoring framework for dienogest and other hormonal treatments in women with endometriosis.

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Abstract

INTRODUCTION: 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. METHODS: 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. PLANNED OUTCOMES: 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. TRIAL REGISTRATION: European Union Electronic Register of Post-Authorisation Studies (EU PAS) no. 1613, Clinicaltrials.gov: NCT01266421.

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Condition tags

endometriosischronic_pelvic_paindysmenorrheadyspareunia

MeSH descriptors

Endometriosis Hormone Antagonists Nandrolone Adult Endometriosis Endometriosis Europe Female Germany Hormone Antagonists Hormone Antagonists Humans Nandrolone Nandrolone Nandrolone Pelvic Pain Pelvic Pain Pelvic Pain Prospective Studies Research Design

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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