The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.
- Conditions
- Migraine without auraTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 27
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method