The NOVA-NOA Trial A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
The NOVA-NOA trial is an important study investigating a new medication called Leflutrozole for men experiencing infertility due to a condition where no sperm are found in their ejaculate (non-obstructive azoospermia). This type of infertility means there's a problem with sperm production, not a blockage. The main goal of this study is to find out if Leflutrozole can help men start producing sperm that can be found in their semen within 12 to 20 weeks. Researchers will also be looking at how this medicine affects hormones, general health markers like blood sugar and cholesterol, and a man's overall well-being. This is a Phase II study, meaning it's exploring how well the medicine works and if it's safe.
At a glance
What is this study about?
This study, called NOVA-NOA, is looking for a new way to help men who are struggling to have children because of a condition called non-obstructive azoospermia. This means that when a man ejaculates, there are no sperm present, not because of a blockage, but because his body isn't making enough sperm to get into the ejaculate. This can be a very challenging situation for couples hoping to start a family.
We are testing a new medicine called Leflutrozole. The main thing we want to find out in this study is if taking Leflutrozole can help men start producing sperm that can be found in their semen. We'll be checking this between 12 and 20 weeks after they start the treatment. If the medicine helps sperm appear in the ejaculate, it could be a significant step forward for men with this type of infertility.
Beyond just looking for sperm, we'll also be closely monitoring many other things. This includes checking various hormone levels in the blood, like those important for reproduction, and looking at general health indicators such as blood sugar, cholesterol, and even bone health. The study will also examine how the medicine affects sperm count, movement, and shape if sperm are found, and check for any changes in the female partner if she is also taking part.
Key takeaways
- The NOVA-NOA trial is testing a new medicine, Leflutrozole, for male infertility.
- It aims to see if Leflutrozole can help men with non-obstructive azoospermia produce sperm.
- The study also looks at how the medicine affects hormones and general health.
- Men aged 18 and over with this specific infertility condition may be eligible.
- Participation involves taking the medicine and attending regular check-ups.
- You have the right to leave the study at any time.
Who may be eligible?
To be considered for this study, you must be a man aged 18 years or older. There is no upper age limit, meaning older men can also participate if they meet other criteria.
The study is specifically for men who have been diagnosed with male infertility due to non-obstructive azoospermia. This means you have not been able to father a child, and tests have shown no sperm in your ejaculate, and that this isn't due to a physical blockage.
More detailed health checks will be done by the study team to make sure this trial is safe and appropriate for you.
- Are you a man?
- Are you 18 years old or older?
- Have you been diagnosed with male infertility where no sperm are found in your ejaculate (non-obstructive azoospermia)?
- Are you able to attend regular appointments at the study site?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the new medication, Leflutrozole. You would need to attend several appointments with the study team over a period of time, likely at least 12 to 20 weeks, and possibly longer for follow-up. These appointments would involve providing blood samples, and semen samples (if possible), for the researchers to monitor your hormone levels, general health, and importantly, to check for the presence of sperm. There might also be other tests, such as urine samples, to gather comprehensive information about your health. The duration of your participation will be explained in full detail by the study team.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is 'non-obstructive azoospermia'?
It's a type of male infertility where no sperm are found in a man's ejaculate because his body isn't producing enough sperm, not because there's a blockage.
What is Leflutrozole?
Leflutrozole is a new investigational medicine that researchers are testing to see if it can help men with non-obstructive azoospermia produce sperm.
How long will the study last for me?
The main part of the study where researchers check for sperm in your ejaculate will be between 12 and 20 weeks, but your full participation might involve follow-up appointments extending beyond that time. The study team will provide precise details.
Will I know if the medicine is working for me?
Yes, the main goal is to see if sperm appear in your ejaculate. The study team will be able to share relevant results with you as the trial progresses.
Do I have to pay to participate?
No, you do not have to pay to participate in a clinical trial. All study-related medication, tests, and care are provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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