2024-512014-17-02CompletedPhase 1/2
The headache-inducing effects of sildenafil in men and women with episodic migraine without aura.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 9 Jun 2024
- Start date
- 1 Nov 2024
- Lead sponsor
- Syddansk Universitet (University of Southern Denmark)
- Diseases
- Migraine
- EU CT number
- 2024-512014-17-02
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 27
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syddansk Universitet (University of Southern Denmark) | Odense M | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.