A Phase 2a, Randomised, Double-blind, Parallel and Placebo-controlled Trial Investigating Safety and Efficacy of LIB-01 in Treatment of Erectile Dysfunction
This research study is investigating a new medication, LIB-01, for men experiencing erectile dysfunction (ED), which is when a man has consistent difficulty getting or keeping an erection firm enough for sex. The main goal is to find out how safe LIB-01 is and how well it works to improve erections over a 4-week period. Participants will be randomly assigned to receive either LIB-01 or a placebo, which is an inactive substance that looks just like the real medication. This helps researchers fairly compare the new drug's effects. We will be checking how participants' erection difficulties change using a special questionnaire and closely monitoring for any side effects or changes in their health.
At a glance
What is this study about?
This study is exploring a new treatment called LIB-01 for men who experience erectile dysfunction (ED). ED means you consistently have trouble getting or keeping an erection firm enough for sexual activity. It's a common condition that can affect a man's quality of life.
The main purpose of this study is to see if LIB-01 is safe and effective in helping men with ED. Researchers will be comparing LIB-01 to a 'placebo' – this is a harmless, inactive substance that looks exactly like the real medication. Some participants will receive LIB-01, and others will receive the placebo. Neither you nor the study team will know who is getting which, making the results fairer and more reliable. The study will mainly look at how your erections change over 4 weeks using a questionnaire, and we'll be very carefully checking for any side effects.
We hope this study will give us important information about LIB-01 and whether it could be a helpful new option for men living with ED. Understanding how a new medication works and what its potential side effects are is a vital step in making new treatments available.
Key takeaways
- This study is for men with erectile dysfunction (ED).
- It's testing a new medication called LIB-01.
- The study compares LIB-01 to a dummy treatment (placebo).
- It primarily checks how safely LIB-01 works over 4 weeks.
- Participation involves regular clinic visits and health checks.
- You can stop participating at any time.
Who may be eligible?
This study is open to men aged 18 years and older who are experiencing erectile dysfunction (ED). There is no upper age limit, so men of all adult ages can potentially take part.
To be considered for this study, you must have a formal diagnosis of erectile dysfunction. This means you consistently have difficulty getting or maintaining an erection firm enough for satisfactory sexual activity.
Other specific health requirements or conditions might make you unsuitable for the study, which the study team will discuss with you. These could include certain medical conditions, medications you are currently taking, or other factors related to your overall health.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man?
- Are you 18 years old or older?
- Have you been diagnosed with erectile dysfunction?
- Are you comfortable taking a study medication that comes as a liquid?
What does participation involve?
If you decide to take part in this study, you will be given a study medication (either LIB-01 or the placebo) to take as prescribed. The medication comes as a powder that you mix to create a liquid suspension. You'll have regular visits to the study clinic where the medical team will check on your health and progress.
During these visits, you can expect to have various assessments. These might include answering questionnaires about your erections and sexual activity (like the International Index of Erectile Function), having your blood and urine tested, checking your blood pressure and heart rate (vital signs), and having an electrocardiogram (ECG) to monitor your heart. The study will last for a set period, and you'll have follow-up appointments to make sure everything is going well. The total duration of your participation, including all visits and follow-ups, will be clearly explained by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedNetherlands
- —UnverifiedDenmark
- —UnverifiedSweden
Common questions
What is erectile dysfunction (ED)?
ED is when a man regularly has trouble getting or keeping an erection firm enough for sexual activity.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the active drug but contains no medicine. It helps researchers compare the real drug's effects fairly.
Will I know if I'm getting the real drug or the placebo?
No, neither you nor your study doctor will know who is receiving which treatment during the study. This is called 'double-blind'.
How long will this study last?
The main part of the study assessing the drug's effect on erections will be for 4 weeks. The full duration of your participation, including follow-up, will be explained by the study team.
What kind of tests will I have?
You'll have questionnaires, blood and urine tests, blood pressure and heart rate checks, and heart monitoring (ECG) during your visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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