Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Single Dose Pharmacokinetics and Relative Bioavailability of Sayana Press via Upper Arm Injection Relative to Anterior Thigh and Abdomen

This study is about a long-acting birth control injection called Sayana Press, which helps prevent pregnancy for a long time. Researchers want to understand how your body uses this medicine when it's given in different places, specifically the upper arm, the front of the thigh, and the tummy. By comparing these injection sites, they hope to find the most effective and consistent way for the medicine to work. This type of study is an early step in understanding new medicines or new ways to give them, focusing on how the body handles the drug.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

27 Jun 2024

long-term female contraception

What is this study about?

This study is about a type of birth control injection called Sayana Press. This injection is designed to offer long-term protection against pregnancy. The main goal of this particular study is to understand how your body handles the medicine in Sayana Press when it's given in different places on your body.

Specifically, the researchers want to compare how the medicine is absorbed and used when injected into your upper arm, the front of your thigh, and your tummy area. They are looking to see if one injection site allows the medicine to work better or more consistently than others. This is important because understanding how your body takes in the medicine helps doctors know the best way to give it to make sure it's as effective as possible.

This kind of research is an early but important step in developing and improving medicines. It helps scientists learn vital information about how a drug behaves in the human body before it becomes widely available or changes are made to how it's used. The findings from this study could help make Sayana Press an even better option for women considering long-term birth control.

Key takeaways

This study evaluates a long-term birth control injection called Sayana Press.
It compares how the medicine works when injected in the arm, thigh, or tummy.
The goal is to find the best way to give the injection for effective contraception.
Only women aged 18 and over can participate.
Participation involves injections and regular health checks, including blood tests.

Who may be eligible?

This study is looking for women aged 18 and older. There isn't an upper age limit mentioned, so women of all adult ages could potentially take part.

To be eligible, you would need to be a healthy female volunteer. You would also need to meet specific health criteria that the study team would check. This is to make sure the study is as safe as possible for you and that the results are clear.

Things that might prevent you from taking part include certain health conditions, taking particular medications, or if you are pregnant or breastfeeding. The study team will discuss all these details with you thoroughly to see if you're a good fit.

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?
Are you 18 years old or older?
Are you generally healthy?
Are you not currently pregnant or breastfeeding?
Are you able to attend clinic appointments regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the Sayana Press injection. This injection would be given in three different places during the study: your upper arm, your thigh, and your tummy. The study would involve several visits to a clinic for these injections and for health checks. You would have your blood taken regularly to see how your body is using the medicine. You might also have other tests to check your overall health throughout the study. The total time you'd be involved in the study would depend on the specific schedule, but these types of studies usually involve a few follow-up appointments over a period of weeks or months.

Potential risks and benefits

Taking part could offer the benefit of contributing to our understanding of a common long-term contraception. This could help improve how Sayana Press is used for many women in the future. As with any medical procedure, there are potential risks, such as injection site pain, bruising, or mild side effects from the medication, which the study team will explain fully. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is Sayana Press?

Sayana Press is a type of birth control injection that offers long-term protection against pregnancy.

Why are they injecting it in different places?

Researchers want to see if the medicine works differently or is absorbed better when given in the arm, thigh, or tummy.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and medication are provided free of charge.

Can men take part in this study?

No, this study is specifically for women, as it focuses on female contraception.

What happens if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your usual healthcare.