The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.
Key facts
- Where
- Odense M, DániaSee the site
- Phase
- 1/2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Dánia
- Syddansk Universitet (University of Southern Denmark)Odense M, DániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Syddansk Universitet (University of Southern Denmark)
- Trial code
- EU 2024-512014-17-02
- Record updated
- 2024. augusztus 3.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; Known allergy to any component of sildenafil "Orion"; Hypertension (> 150/100 mmHg) or hypotension (< 90/50 mmHg) at the Screening Visit; Anamnestic or clinical signs of cardiovascular diseases, anatomical abnormalities of the penis, retinal disorders, sickle cell anemia, multiple myeloma and/or leukemia; Pregnant and/or breastfeeding women; 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.