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The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.
EU CTIS ID: 2024-512014-17-02
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.