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Study of Sildenafil for Men with Erectile Dysfunction to Evaluate Their Ability to Safely Decide on Using This Medication Independently

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What is this trial about?

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

This study examines erectile dysfunction, which is a condition where men have difficulty achieving or maintaining an erection sufficient for sexual activity. The treatment being evaluated in this study is sildenafil 100 mg, which is provided as film-coated tablets taken by mouth. The purpose of the study is to assess whether participants can independently make safe decisions about whether it is appropriate for them to use this medication using a dedicated diagnostic tool.

During the study, participants will use the diagnostic tool to help them determine if it is safe for them to take the medication. The study will look at how well participants follow the prescribed way of taking the medicine, whether the medication is effective in allowing them to achieve and maintain an erection sufficient for sexual intercourse, and how many sexual encounters are satisfactory after taking the medication. The study will also monitor any unwanted effects that may occur during the treatment period, which can last up to 42 days.

This is a multicenter study, meaning it will take place at several different locations. Participants will be adult men who are sexually active and planning to have sexual interactions. Throughout the study, information will be collected about how participants use the medication and their experiences with it to understand if they can safely manage their treatment independently.

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

    Initial assessment and enrollment

    Your participation in the study will begin after you have signed the informed consent form.

    You will need to confirm that you are 18 years of age or older, sexually active, and planning to have sexual interactions.

    You will be asked to confirm that you understand and are able to follow the study procedures.

  2. Step 2

    Use of diagnostic tool

    You will be provided with a dedicated diagnostic tool to help you assess whether it is appropriate for you to use the medication.

    This tool is designed to help you make an independent and safe decision about whether sildenafil 100 mg is suitable for your condition.

    The tool will guide you through questions related to your health status and potential contraindications.

  3. Step 3

    Medication use if appropriate

    If the diagnostic tool indicates that the medication is appropriate for you, you may receive sildenafil 100 mg in the form of film-coated tablets.

    The medication is taken orally (by mouth).

    The medication is intended for the treatment of erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

    You should take the medication as prescribed and follow the instructions provided to you.

  4. Step 4

    Monitoring of medication effects

    During the study, you will be asked to monitor and report whether the medication helped you achieve and maintain an erection sufficient for sexual intercourse.

    You will also be asked to assess whether your sexual intercourses were satisfying after taking the medication.

    Information about how you followed the prescribed medication regimen will be collected to assess compliance.

  5. Step 5

    Safety monitoring

    Throughout the study, any safety concerns or side effects you experience will be monitored.

    You should report any unusual symptoms or health changes that occur during your participation in the study.

  6. Step 6

    Study completion

    The study is expected to be completed by June 30, 2026.

    Your participation will continue according to the study schedule until all required assessments are completed.

Who can join the trial?

4 criteria

  • You must be a male who is 18 years old or older
  • You must be sexually active, which means you are currently engaging in sexual activity and planning to continue having sexual interactions
  • You must sign a document called an informed consent form before starting the study, which means you agree to take part after understanding what the study involves
  • You must be able to understand and follow the study procedures, which are the steps and instructions you will need to complete during the study

Who cannot join the trial?

10 criteria

  • Women cannot participate in this study, only men are included
  • Children and young people under 18 years of age cannot participate in this study
  • People who are allergic to sildenafil, which is the medicine being tested, cannot participate
  • People who are currently taking medicines called nitrates, which are used to treat chest pain, cannot participate because combining them with sildenafil can be dangerous
  • People who have had a heart attack or stroke in the past 6 months cannot participate
  • People with severe heart problems or very low blood pressure cannot participate
  • People with severe liver problems, which means the organ that cleans the blood is not working properly, cannot participate
  • People with severe kidney problems, which means the organs that filter waste from the blood are not working properly, cannot participate
  • People with certain eye conditions that affect the retina, which is the part of the eye that helps you see, cannot participate
  • People who are unable to understand or follow the study instructions cannot participate
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Investigated drugs

Sildenafil is a medication used to treat erectile dysfunction, which is when a man has difficulty getting or keeping an erection. This medicine works by helping to relax blood vessels and increase blood flow to the penis during sexual stimulation. In this trial, participants will use a diagnostic tool to help them decide whether it is safe for them to use this medication on their own.

What is already known about the treatment

Sildenafil Polpharma 100 mg – Sildenafil is a medication taken by mouth in tablet form that is widely used and well-established in medical practice for treating erectile dysfunction, a condition where men have difficulty achieving or maintaining an erection. This medicine works by blocking an enzyme called phosphodiesterase type 5, which leads to relaxation of blood vessels in the penis and allows increased blood flow, making it easier to get an erection when sexually stimulated. Sildenafil belongs to a group of medications known as phosphodiesterase type 5 inhibitors, and it is typically taken about 30 minutes to an hour before sexual activity. The 100 mg dose is one of the standard strengths available for this treatment.

Investigated diseases

Erectile Dysfunction – Erectile dysfunction is a condition where a man has difficulty achieving or maintaining an erection firm enough for sexual intercourse. This condition can occur occasionally or persistently, affecting sexual performance and satisfaction. The problem involves insufficient blood flow to the penis or issues with the nerves that control erections. Erectile dysfunction can develop gradually over time or appear suddenly. Various factors can contribute to this condition, including physical health issues, psychological factors, or a combination of both. The condition can affect men of different ages, though it becomes more common with increasing age.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522923-81-00Protocol code844700336/0156/1Estimated enrolment200 patientsSponsorZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

sourced from the EU Clinical Trials Register and site verification

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