Migraine-inducing effects of sildenafil in men with migraine without aura: Protocol for a randomized, placebo-controlled crossover trial

Abstract

Background This study aims to assess the migraine-inducing effects of sildenafil in men with migraine without aura. While sildenafil has been shown to provoke migraine in women, its effect on men remains unknown. Methods The trial will enroll 12 men and 15 women, all diagnosed with migraine without aura. The men will participate in a randomized, placebo-controlled crossover trial and the women in an open-label study. Participants will be monitored for migraine attacks and associated symptoms for 12 h post-administration. The primary endpoints include the incidence of migraine attacks in sildenafil-treated men compared to placebo and between sildenafil-treated men and women. Secondary endpoints are headache incidence, heart rate, mean arterial pressure, and adverse events. Conclusion The findings will contribute to a better understanding of sex-related differences in migraine mechanisms, potentially leading to more tailored treatment approaches. Trial registration: The trial is registered in the Clinical Trial Information System (CTIS) of the European Union under the number 2024-512014-17-02.