A multicenter, prospective clinical TRrial evaluating patient’s ability to make an independent and safe decision regarding the USe of the medicinal product Sildenafil Polpharma100 mg indicated in the Treatment of erectile dysfunction. TRUST Trial on Responsible Use and Self-assessed Treatment.
The TRUST study is investigating a common treatment for erectile dysfunction, which is when a man has difficulty getting or keeping an erection firm enough for sex. This study specifically looks at a 100mg Sildenafil (similar to Viagra) tablet, sometimes sold as MAXIGRA. Researchers want to understand if men, on their own, can safely and effectively decide when and how to use this medication. They are checking how consistently participants take the medication, how well it helps achieve satisfying sexual intercourse, and if there are any safety concerns. This research aims to provide insights into how men might responsibly manage their treatment for erectile dysfunction with less direct medical supervision.
At a glance
What is this study about?
This study, called TRUST, is all about understanding how men manage their erectile dysfunction. Erectile dysfunction is a common issue where men have trouble getting or keeping an erection firm enough for sexual activity. The researchers are focusing on a particular medication, Sildenafil 100mg, which is a tablet often used to treat this condition.
The main idea behind the TRUST study is to see if men can safely and effectively make their own decisions about using this medication. This means they are looking at whether men can figure out if the tablet works for them to have satisfying sex, and if they can use it responsibly without needing to consult a doctor every time. This kind of research is important because it could help make treatment for erectile dysfunction more flexible and accessible for men who need it.
The study will carefully watch how participants use the medication, how well it helps them, and if there are any unexpected problems. By gathering this information, the researchers hope to learn more about how men can take an active role in managing their own treatment for erectile dysfunction.
Key takeaways
- This study is about men with erectile dysfunction.
- It uses Sildenafil 100mg (like MAXIGRA) to treat the condition.
- The research explores if men can responsibly and effectively manage their own treatment.
- You must be an adult male (18 or older) to participate.
- The study assesses how well the medication works and if it's safe when self-administered.
- Participants will report on their experience with the medication and sexual activity.
Who may be eligible?
To take part in this study, you need to be a man. You must also be at least 18 years old. There is no upper age limit, so older men can also join.
Since the study is about erectile dysfunction, you would need to be someone who experiences this condition.
The study will involve taking a specific medication (Sildenafil 100mg), so you'd need to be able to take tablets and potentially have sexual activity to assess the medication's effects.
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?
- Do you experience erectile dysfunction?
- Are you able to take tablets?
- Are you able to engage in sexual activity to assess the medication's effects?
What does participation involve?
If you join this study, you will be given a 100mg sildenafil tablet (known as MAXIGRA) to use. The study team will check to see how well you follow the instructions for taking the medication. They will also ask you to report back on whether the medication helped you achieve and keep an erection firm enough for satisfactory sexual intercourse. You'll need to share if the sexual experiences were satisfying. The team will also be monitoring your health to make sure the medication is safe for you. The total duration of your participation is not specified but will involve taking the medication and reporting on its effects and any side effects.
Potential risks and benefits
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Common questions
What is erectile dysfunction?
Erectile dysfunction (ED) is when a man has difficulty getting or keeping an erection firm enough for sexual intercourse.
What is Sildenafil?
Sildenafil is a common medication used to treat erectile dysfunction. It helps increase blood flow to the penis, making it easier to get and maintain an erection.
What is MAXIGRA?
MAXIGRA is a brand name for a 100mg sildenafil tablet, similar to Viagra.
Will I have to pay for the medication?
Typically, in clinical studies, the study medication is provided to participants at no cost, but this should be confirmed with the study team.
What does a 'Phase IV' study mean?
A Phase IV study looks at a medicine once it's already approved and available. It aims to gather more information about its long-term safety, effectiveness, or how different groups of people use it in real-world situations, rather than during initial development.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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