Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Etonogestrel 68 mg Implant in Healthy Pre-Menopausal, Non-Pregnant Female Participants.

This study is looking at a new version of the etonogestrel implant. This implant is a small, flexible rod placed under the skin of your upper arm to prevent pregnancy. The main goal is to check if this new version releases the medicine, etonogestrel, into your body in the same way as the original implant that's already available. This is important to make sure it will be just as effective and safe. We are looking for healthy women, aged 18 and over, who are not pregnant and haven't started menopause yet. This research helps ensure new medications work as expected before they become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

04 Apr 2025

No medical condition

What is this study about?

This research study is focused on a type of contraception called an etonogestrel implant. You might know it as a small, flexible rod that's (usually) placed under the skin in your upper arm. This implant works by slowly releasing a hormone called etonogestrel into your body, which helps to prevent pregnancy.

The main purpose of this study is to compare a new version of this implant with the one that's already used. We want to make sure that the new implant releases the hormone into your body in exactly the same way as the current one. This is called 'bioequivalence'. If they are bioequivalent, it means the new implant should be just as effective and safe as the one doctors already prescribe.

Studies like this are a very important first step when developing new medicines or new versions of existing ones. They help us understand how the medicine behaves in the human body. By ensuring the new implant delivers the medicine consistently and effectively, this research contributes to making safe and reliable contraception available.

Key takeaways

The study is comparing a new version of the etonogestrel contraceptive implant.
It aims to ensure the new implant works the same way as the current one.
It's for healthy, non-pregnant women who are not yet menopausal.
Participation involves medical checks and monitoring the implant's effects.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, we are looking for women who are at least 18 years old. There is no upper age limit, but you must not have gone through menopause yet.

An important part of this study is that you need to be generally healthy. This means you shouldn't have any significant medical conditions that could affect how your body reacts to the implant or the study procedures. We also need to confirm that you are not pregnant when you start the study.

These checks are in place to make sure the study is as safe as possible for everyone involved and that the results we get are clear and accurate.

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 18 years old or older?
Are you generally healthy, without significant long-term illnesses?
Are you currently not pregnant?
Have you not gone through menopause yet?
Are you willing to potentially use this type of birth control for the study duration?

Answer every question to see your result.

What does participation involve?

We don’t have all the details about what taking part involves right now, as the full plan wasn't provided. However, generally, studies like this often include several visits to a clinic. You would likely have a health check, and some blood tests, and the implant would be inserted. There would then be follow-up visits, which might involve more blood tests to measure the hormone levels from the implant. These visits are to see how your body is responding to the implant and how much of the medicine it's releasing over time. The total time you would be involved in the study can vary, but it often spans several months.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of closely monitored medical care and contributing to medical research. There are potential risks associated with any medical procedure, such as discomfort or bruising when the implant is inserted or removed, and the usual side effects linked to hormonal contraception. You will be fully informed of all known risks before deciding to take part, and you are always free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Portugal

Common questions

What is an etonogestrel implant?

It's a small, flexible rod placed under the skin of your upper arm that slowly releases a hormone to prevent pregnancy, acting as a form of birth control.

Why is this study being done?

This study is comparing a new version of the etonogestrel implant to the one currently available, to make sure the new version works just as effectively and safely.

Do I have to stop using my current birth control?

The study team will give you specific advice on birth control methods during the study. This will ensure your safety and the accuracy of the study results.

Will I get paid to take part?

Payment for participation or help with travel costs is common in these types of studies. The study team will provide full details if this is the case.

What happens after the study ends?

Once the study is over, the implant would typically be removed (if still in place), and you would return to your usual medical care and preferred method of contraception.