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Study on Headache Effects of Sildenafil and Placebo in Men and Women with Episodic Migraine Without Aura

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication sildenafil on individuals who experience migraine without aura. Migraines are severe headaches that can cause throbbing pain, often accompanied by nausea and sensitivity to light and sound. The study aims to understand how sildenafil, a medication commonly used for other conditions, might influence the occurrence of headaches and migraine-like attacks in both men and women who suffer from this type of migraine.

Participants in the study will receive either sildenafil or a placebo, which is a substance with no active medication, to compare the effects. The study will observe the differences in headache occurrences between those treated with sildenafil and those given a placebo. The trial will also look at how sildenafil affects heart rate and blood pressure in men with migraines, as well as any side effects that may occur.

The study will take place over a period of time, during which participants will be monitored for any changes in their migraine patterns and overall health. The goal is to gather information that could help in understanding the potential role of sildenafil in managing migraines without aura, providing insights that could benefit future treatments for this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, weight, and frequency of migraine attacks.

    Participants must be between 18 and 50 years old, weigh between 60 and 90 kg, and have experienced between one and six migraine attacks in the last 8 weeks.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline data. This includes a review of medical history and current health status.

    Participants are required to be fluent in Danish or English and, for women, to use safe contraception throughout the study.

  3. Step 3

    Medication administration

    Participants receive either sildenafil or a placebo. Sildenafil is administered in the form of a 100 mg film-coated tablet taken orally.

    The purpose is to observe the occurrence of headache and migraine-like attacks in those treated with sildenafil compared to those receiving a placebo.

  4. Step 4

    Monitoring and data collection

    Participants are monitored for the occurrence of migraine-like attacks and headaches.

    Data on heart rate and mean arterial pressure (MAP) are collected to assess any differences between sildenafil and placebo treatments.

  5. Step 5

    Evaluation of adverse events

    The incidence of any adverse events is recorded and compared between the sildenafil and placebo groups.

    This step ensures the safety and well-being of participants throughout the trial.

  6. Step 6

    Completion of the trial

    The trial is estimated to conclude by May 31, 2025.

    Final assessments are conducted to evaluate the primary and secondary endpoints, including the difference in migraine-like attacks and headaches between the treatment groups.

Who can join the trial?

6 criteria

  • Healthy men and women with a diagnosis of migraine without aura. This means they have migraines but do not experience the visual or sensory disturbances that can sometimes come before a migraine.
  • Experience migraines between one and six times in the last 8 weeks.
  • Are between 18 and 50 years old.
  • Weigh between 60 and 90 kg.
  • Can speak and understand Danish or English fluently.
  • Women must use safe contraception during the entire study. This includes methods like hormonal therapies, intrauterine devices, or oral pills.

Who cannot join the trial?

4 criteria

  • Individuals who do not have migraine without aura. A migraine without aura is a type of headache that does not have warning signs like visual disturbances before it starts.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are not male or female, as the study includes both genders.
  • Individuals who are considered part of a vulnerable population, which means people who might need special protection or care.
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Investigated drugs

Sildenafil is a medication commonly used to treat erectile dysfunction and pulmonary hypertension. In this clinical trial, it is being studied to understand its effects on inducing headaches and migraine-like attacks in men and women who experience episodic migraines without aura. The trial aims to observe how this medication might trigger such symptoms in the participants.

What is already known about the treatment

Sildenafil – Sildenafil is administered orally in tablet form. It is currently being studied for its effects on migraine without aura, particularly in inducing headache and migraine-like attacks. The main therapeutic indication for sildenafil is erectile dysfunction, but it is also used for pulmonary arterial hypertension. At the molecular level, sildenafil works by inhibiting an enzyme called phosphodiesterase type 5 (PDE5), which leads to increased blood flow. It is classified as a phosphodiesterase inhibitor.

Investigated diseases

Migraine without aura – This is a type of migraine characterized by recurrent headaches that typically affect one side of the head. The pain is often described as throbbing or pulsating and can be moderate to severe in intensity. Unlike migraines with aura, there are no sensory disturbances or visual changes before the headache begins. The headache can last from a few hours to several days and is often accompanied by nausea, vomiting, and sensitivity to light and sound. Physical activity can worsen the symptoms, leading individuals to seek rest in a quiet, dark environment. The frequency and severity of these headaches can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512014-17-02Estimated enrolment27 patientsSponsorSyddansk Universitet (University of Southern Denmark)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).