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临床试验/CTIS2024-512014-17-02
CTIS2024-512014-17-02进行中(未招募)1 期

The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.

Syddansk Universitet (University of Southern Denmark)0 个研究点目标入组 27 人开始时间: 2024年6月9日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
27

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)
性别
All

入选标准

  • Healthy men and women with a diagnosis of migraine without aura according to the International Classification of Headache disorders., Frequency of migraine between one and six attacks within the last 8 weeks., Age between 18 and 50 years., Weight between 60 and 90 kg., Fluency in Danish or English., Safe contraception (including hormonal therapies, intrauterine devices and/or oral pills) for women during the entire period of the study.

排除标准

  • Any other type of headache (excluding < 3 days of tension-type headache per month), according to the International Classification of Headache Disorders., Anamnestic or clinical signs of mental illness, abuse or smoking., Anamnestic or clinical signs of diseases of any kind considered by the investigating physician relevant for participation in the study., Pregnant and/or breastfeeding women., Known allergy to any component of sildenafil Orion., Member of investigational site staff or relative of investigators., Headache less than 24 hours before the start of the experiment., Drinking coffee, cola or alcohol less than 12 hours before the start of the experiment., Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit., Assumption of analgesic medications in the 48 hours preceding the experimental days., Assumption of a-blockers, ritonavir and/or drugs inhibiting the activity of the CYP3A4 enzyme., Anamnestic or clinical signs of cardiovascular diseases, anatomical abnormalities of the penis, retinal disorders, sickle cell anemia, multiple myeloma and/or leukemia.

研究者

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