A Phase 1, open label, randomized, 2-sequence, 2-period, crossover, single center study to evaluate the pharmacokinetics of follitropin alfa from 2 manufacturing processes, administered as a single subcutaneous 450 IU dose to pituitary-suppressed healthy premenopausal female participants.
This study is designed to understand how a fertility drug called follitropin alfa moves through and is processed by the body. It's a very early-stage study involving healthy women who are able to have children, but whose natural hormone levels have been temporarily lowered. Researchers want to compare two different ways of making this drug to see if there are any differences in how the body uses them. Each woman taking part will receive a single dose of the medicine under the skin. This kind of research helps scientists learn important details about new medicines, which can eventually lead to better treatments for conditions like infertility.
At a glance
What is this study about?
You might have heard about fertility treatments, and this study is a small but important step in understanding how some of these treatments work. Specifically, it's looking at a medicine called follitropin alfa, which is often used in people who are trying to get pregnant. The main goal is to figure out how this medicine is absorbed, travels through, and is removed from the body. This is called 'pharmacokinetics.' Think of it like watching a journey – how long it takes to reach different places in the body and how long it stays there.
Researchers are comparing two slightly different ways of making this follitropin alfa medicine. They want to see if these differences in manufacturing affect how the body uses it. This is really key because even small changes in how a medicine is made can sometimes impact how well it works or how quickly it acts. This study takes place in healthy women to ensure that any effects seen are purely due to the medicine itself and not other health conditions.
Understanding these details helps scientists improve fertility treatments. While this study doesn't look at whether the medicine helps with pregnancy directly, the information it gathers is vital for developing and making sure future fertility treatments are as effective and safe as possible. It's a foundational study that builds knowledge for the bigger picture of helping people with infertility.
Key takeaways
- This study helps us understand how a fertility medicine (follitropin alfa) works in the body.
- It compares two different versions of the medicine.
- Participation involves temporary hormone lowering and receiving the study medicine.
- It's an early-stage study in healthy women, not a fertility treatment itself.
- The goal is to improve future fertility treatments for infertility.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for women who are healthy and between the ages of 18 and any upper age limit, as long as they are still able to have children (premenopausal).
To be considered, you must not be pregnant or breastfeeding, and you should be able to commit to the study schedule. The study will involve temporarily lowering your natural hormone levels, so if you have any conditions that would make this unsafe for you, you would not be able to join.
The health team will conduct a thorough check to make sure participating is safe and suitable for you. They will explain everything clearly during this process.
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 woman aged 18 or older?
- Are you still having periods (premenopausal)?
- Are you generally healthy?
- Are you not pregnant or breastfeeding?
- Are you willing to have temporary hormone lowering and drug injections?
- Can you commit to regular clinic visits?
What does participation involve?
If you decide to take part, you'll visit a study centre multiple times. First, you'll have some initial health checks to see if you're suitable. Then, your natural hormone levels will be temporarily lowered using another medicine, which often involves daily injections or a nasal spray for a period. After this, you will receive two single doses of the follitropin alfa medicine, given as an injection just under your skin, with a break in between the doses. Blood samples will be taken frequently after each injection to see how the medicine travels through your body. You'll also have regular health checks. The total time you'd be involved in the study, including all visits and follow-up, would be fully explained before you agree to participate.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is follitropin alfa?
Follitropin alfa is a medicine often used in fertility treatments to help with egg development in women.
Why are you studying healthy women?
Studying healthy women helps researchers understand how the medicine works in the body without other health conditions affecting the results, making the information very clear.
What does 'pituitary-suppressed' mean?
It means your natural hormone production from a gland in your brain (the pituitary) will be temporarily lowered using another medicine, to make sure the study only measures the effects of the follitropin alfa.
Will I become pregnant during this study?
No, this study is not designed to help you get pregnant. Steps will be taken to prevent pregnancy, and you should not be trying to conceive while participating.
Will I be paid for taking part?
Clinical trials often offer reimbursement for travel and time. This will be discussed with you in detail if you are considered for the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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