The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Difference in the occurrence of migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura.
研究概览
简要总结
The purpose of the trial is to investigate the occurrence of headache and migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura and in sildenafil-treated women with migraine without aura.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
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 α-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.
结局指标
主要结局
Difference in the occurrence of migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura.
Difference in the occurrence of migraine-like attacks in sildenafil- and placebo-treated men with migraine without aura.
Difference in the occurrence of migraine-like attacks in sildenafil-treated men and women with migraine without aura.
Difference in the occurrence of migraine-like attacks in sildenafil-treated men and women with migraine without aura.
次要结局
- Difference in heart rate and mean arterial pressure (MAP) between sildenafil- and placebo-treated men with migraine without aura
- Difference in the occurrence of headache in sildenafil- and placebo-treated men with migraine without aura.
- Difference in the incidence of adverse events between sildenafil- and placebo-treated men with migraine without aura
研究者
Lanfranco Pellesi
Scientific
Syddansk Universitet (University of Southern Denmark)