Venous Thromboembolism Risk Associated with Relugolix-Estradiol-Norethisterone Acetate Combination Therapy Article Swipe
YOU?
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· 2025
· Open Access
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· DOI: https://doi.org/10.1210/jendso/bvaf190
Background Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, is effective in treating uterine myomas and endometriosis. However, concerns persist regarding the venous thromboembolism (VTE) risk associated with its combination with oral estradiol (E2) and norethisterone acetate (NETA). Objective This expert opinion evaluates the thrombotic risk of relugolix-CT based on pharmacological data, clinical trials, and regulatory assessments. Methods A review of pivotal trials (LIBERTY 1, LIBERTY 2, SPIRIT 1, SPIRIT 2), regulatory reports (EMA, FDA), and real-world safety data was conducted, focusing on hemostatic effects and VTE risk. Results Relugolix monotherapy reduces estrogen levels, leading to minor decreases in coagulation factors. While E2 and NETA mitigate hypoestrogenic effects, concerns about their prothrombotic potential remain. However, clinical trials and post-marketing surveillance have not shown a significant increase in VTE risk. A meta-analysis suggests that estradiol-based regimens have a lower thrombotic risk than ethinylestradiol-based therapies. Conclusions The VTE risk of relugolix-CT appears lower than that of traditional combined oral contraceptives. Nonetheless, patient selection is essential, particularly for those with thrombotic risk factors. Continued real-world surveillance is crucial to refining its safety profile in clinical practice.
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1210/jendso/bvaf190
- OA Status
- gold
- OpenAlex ID
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https://doi.org/10.1210/jendso/bvaf190Digital Object Identifier
- Title
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Venous Thromboembolism Risk Associated with Relugolix-Estradiol-Norethisterone Acetate Combination TherapyWork title
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articleOpenAlex work type
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enPrimary language
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2025Year of publication
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2025-11-21Full publication date if available
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Marie Didembourg, Charles Chapron, Philippe Descamps, Florence Trémollières, Nathalie Chabbert‐BuffetList of authors in order
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https://doi.org/10.1210/jendso/bvaf190Publisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.1210/jendso/bvaf190Direct OA link when available
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0Total citation count in OpenAlex
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