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On February 28, 2025, the FDA required class-wide labeling changes for all testosterone products based on the TRAVERSE clinical trial and required postmarket blood-pressure monitoring studies: Cardiovascular boxed warning removed - TRAVERSE found no increase in major adverse cardiovascular events among men treated for hypogonadism

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found that fast escalation to 8 mg produced GI adverse events in 50% of participants, compared to roughly 35% with gradual titration (Rosenstock et al., Lancet, 2023)

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