Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of FE 999049 for treatment of men with idiopathic infertility

This research study is looking at a new treatment called FE 999049 for men who have unexplained infertility. This means they are having difficulty having a baby with their partner, and doctors haven't found a clear reason why, even after checks. Sometimes, this can involve issues with sperm, like having too few or sperm that don't swim well. The study aims to find out if this new medicine can help improve the chances of a natural pregnancy happening within nine months of the man starting the treatment. It's a 'Phase II' study, which means it's an earlier stage of testing, focusing on whether the treatment works and is safe. Some men will get the actual medicine, and others will get a dummy medicine (placebo) to fairly compare the results. The medicine is given as an injection under the skin using a pre-filled pen.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ferring Pharmaceuticals A/S

Enrolment target

197

Start

17 Nov 2023

Idiopathic male infertility (including oligoasthenozoospermia).

What is this study about?

This study is about a new medicine called FE 999049, and it's for men who are experiencing infertility without a clear explanation. This condition is sometimes called 'idiopathic infertility' and can include situations where a man has a low number of sperm or sperm that don't move as well as they should. The main goal of this research is to see if this new medicine can help couples achieve a natural pregnancy within nine months of the male partner starting treatment. A 'natural pregnancy' in this study means that the female partner becomes pregnant and the baby's heartbeat is seen on an ultrasound scan.

This study is designed to be fair and accurate. Some men in the study will receive the active medicine, while others will receive a 'placebo', which looks exactly like the medicine but doesn't contain any active ingredients. Neither the participants nor their doctors will know who is getting which – this is called 'double-blind'. This approach helps researchers objectively compare the effects of the new medicine against not getting the active treatment. The medicine, if you are given it, comes in a pre-filled pen and is given as an injection just under the skin.

Because this is a 'Phase II' study, it means it's an important step in developing new medicines. At this stage, researchers are trying to understand if the treatment works for the condition it’s designed for and to learn more about its safety. If it shows promise in this phase, it could move on to larger studies. For couples dealing with unexplained infertility, this research offers a chance to explore a potential new treatment option.

Key takeaways

This study tests a new medicine for men with unexplained infertility.
It aims to see if the medicine improves chances of natural pregnancy within 9 months.
Some participants get the medicine, others a dummy treatment (placebo).
The medicine is given as an injection under the skin.
It's a Phase II study, focusing on effectiveness and safety.
Participants must be male and 18 years or older.

Who may be eligible?

This study is specifically for men who are experiencing infertility that doctors can't fully explain. This might include issues like having a lower sperm count or sperm that aren't swimming very well.

To be considered for this study, you must be a man 18 years old or older. There isn't an upper age limit mentioned in the eligibility criteria.

All participants will need to meet specific health criteria, which your study doctor will discuss with you. These checks help make sure the study is safe for you and that the results are clear.

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 unexplained infertility?
Are you currently trying to conceive with your female partner?
Are you willing and able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for check-ups and assessments. These visits will likely involve physical examinations, blood tests, and potentially providing sperm samples. The specific number and frequency of visits will be explained by the study team.

The medicine (or placebo) is given as an injection under the skin using a pre-filled pen. You will be shown how to administer this, or it may be given by a healthcare professional. You'll be taking this medication for a set period, which the study team will explain.

After you start the treatment, the study will monitor your journey and that of your female partner for up to nine months to see if a natural pregnancy occurs. There will likely be follow-up appointments after you finish taking the medication to monitor your health and any effects of the treatment. The total duration of your participation in the study will be fully detailed by the research team.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your chances of achieving a natural pregnancy if the new medicine works as hoped. However, like all medicines, there could be potential risks or side effects from taking FE 999049, or from receiving injections. The study team will explain all known or potential risks to you in detail. There is also no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Sweden
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Unverified
Denmark
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Unverified
Belgium
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Unverified
Germany
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Unverified
Italy

Common questions

What does 'unexplained infertility' mean?

It means doctors haven't found a clear reason for why a couple is struggling to conceive, even after common tests.

What is a 'Phase II' study?

It's an early stage of testing a new medicine to see if it works for the condition it's designed for and to learn more about its safety.

Will I know if I'm getting the real medicine or a dummy injection?

No, neither you nor your doctor will know. This is called 'double-blind' and helps ensure the study results are fair.

How is the medicine given?

It's given as an injection just under the skin using a pre-filled pen.

What happens if a pregnancy occurs during the study?

The study will track if your female partner becomes pregnant and if a baby's heartbeat is seen by ultrasound within nine months of you starting treatment.