Elinzanetant for the Treatment of Menopausal Hot Flashes: A Plain Language Review of the OASIS-1–4 Clinical Trial Results

The authors would like to thank the women and investigators who participated in the OASIS clinical program. Editorial support (in the form of writing assistance, including development of the initial draft based on author direction, collating authors’ comments, and grammatical editing) was provided by Payal Jain, PhD, and Laura Buck, PhD, of Avalere Health Global Limited.

Conceptualization: all authors. Methodology: Caetano, Seitz, Haseli-Mashhadi, Haberland. Data curation: Caetano, Seitz, Haseli-Mashhadi, Haberland. Formal analysis: Haseli-Mashhadi, Pinkerton, Nappi, Soares, Maki, Cardoso, Donders, Brennan, Simon. Supervision: Pinkerton, Nappi, Soares, Maki, Cardoso, Donders, Brennan, Simon. Visualization: all authors. Writing-original draft: all authors. Writing-review and editing: all authors

All the trials were conducted in accordance with the Declaration of Helsinki and the Council for International Organizations of Medical Sciences, International Ethical Guidelines and reported using the CONSORT reporting guideline.

Institutional review board and ethics committee approval were obtained for all study sites. The patient voice was included in aspects of study design through feedback.

JoAnn V. Pinkerton has received grants and consulting fees from Bayer Pharmaceuticals, consulting fees from Pfizer, and independent contract work for Merck & Co. Rossella E. Nappi reported personal fees from Abbott, Astellas, Bayer Healthcare, Besins Healthcare, Biocodex, Exeltis, Fidia, Ibsa, Merck & Co, Novo Nordisk, Organon, Shionogi, Theramex, and Viatris; grants from Gedeon Richter; and nonfinancial support from HRA Pharma outside the submitted work. Claudio N. Soares has received research grants from Ontario Brain Institute, Clairvoyant Therapeutics, Eisai Inc. and performed consultancy work for Otsuka, Bayer, Eisai, Diamond Therapeutics. Pauline M. Maki has performed consultancy work for Astellas, Bayer HealthCare AG, and Pfizer and has equity in Alloy, MidiHealth, and Estrigenix. Fatima Cardoso has received consultancy fees for Amgen, Astellas/Medivation, AstraZeneca, Bayer, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, Gilead, GlaxoSmithKline, Iqvia, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva, Touchime. Cecilia Caetano is an employee of Bayer CC AG, Basel, Switzerland. Christian Seitz and Claudia Haberland are employees of Bayer AG, Berlin, Germany. Nazanin Haseli-Mashhadi is an employee of Bayer plc, Reading, United Kingdom. James A. Simon was principal investigator on the OASIS-1 trial; has received grant/research support from AbbVie, Inc., Bayer Healthcare LLC., Mylan/Viatris Inc., and Myovant Sciences; has acted in an advisory capacity for Ascend Therapeutics, Bayer HealthCare Pharmaceuticals Inc., Besins Healthcare, Biote Medical, LLC, Femasys Inc., Mayne Pharma, Inc., Pfizer Inc., and Vella Bioscience Inc.; has been on speaker’s bureaus for Ascend Therapeutics, Mayne Pharma, Inc., Myovant Sciences, Inc., and Pharmavite LLC.; and is a stockholder (direct purchase) of Sermonix Pharmaceuticals. Donal Brennan, Gilbert Donders, and Georgia Brown declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funded by Bayer Consumer Care AG, Basel, Switzerland.

Result summaries of Bayer’s sponsored clinical trials in drug development phases 1, 2, 3, and 4 are provided in the Bayer Trial Finder application after marketing authorization approval in line with the position of the global pharmaceutical industry associations laid down in the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases”. In addition, results of clinical drug trials will be provided on the publicly funded website and EU Clinical Trials Register in line with the applicable regulations. Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (EU) on or after January 01, 2014 as necessary for conducting legitimate research.

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