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Why were endometrial assessments done?

Published

Evaluation of endometrial safety was requested by the Food and Drug Administration (FDA) for fezolinetant in alignment with the requirements in the FDA Guidance for Industry in this indication

  1. FDA Draft Guidance, Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. January 2003. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/estrogen-and-estrogenprogestin-drug-products-treat-vasomotor-symptoms-and-vulvar-and-vaginal-atrophy.

  2. Data on file.

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