Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Etonogestrel 68 mg Implant in Healthy Pre-Menopausal, Nonpregnant Female Subjects.

This research 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 that releases a hormone to prevent pregnancy. The main goal is to check if this new version works in the body in the same way as the one that's already available and approved. This is called a 'bioequivalence' study. We are looking for healthy women who are able to have children and are not currently pregnant. This kind of study helps make sure new medicines and devices are just as safe and effective as existing ones before they are widely used.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

07 Jun 2023

No medical condition

What is this study about?

This study is a type of research called a 'bioequivalence study.' This means we want to compare a new version of an etonogestrel implant to one that's already approved and widely used. The etonogestrel implant is a form of birth control that's a small rod placed under the skin in your arm. It slowly releases a hormone to prevent pregnancy. Imagine it like comparing two different brands of the same medication – we want to see if they both deliver the medicine to your body in the same way and at the same rate.

The main reason for doing this study is to make sure that the new implant is just as effective and safe as the existing one. Before any new medicine or medical device can be used by the public, it must go through careful testing. This type of study is one of the important first steps in that process.

While this study doesn't look at treating a specific illness (there are no medical conditions involved), it's really important for safe and effective healthcare. By taking part, you’d be helping researchers understand how this new implant works in the body, which can help ensure that people have access to reliable birth control options in the future.

Key takeaways

This study tests a new version of an existing birth control implant.
It's for healthy, non-pregnant women who are 18 or older and not yet started menopause.
The main goal is to ensure the new implant works the same way as the approved one.
Participation involves receiving the implant, regular blood tests, and clinic visits.
You would be helping to develop new, safe birth control options.
You can always change your mind and leave the study at any time.

Who may be eligible?

To join this study, we are looking for women who are generally healthy. This means you shouldn't have any major ongoing health problems or illnesses that could affect how the implant works or interfere with the study procedures.

You also need to be able to have children (pre-menopausal) and not currently pregnant. We're looking for women who are 18 years old or older. There is no upper age limit, as long as you meet the other health criteria.

More specific details about health checks would be discussed if you show interest, but generally, good overall health is key. The study team will conduct tests to make sure it's safe for you to take part.

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 and don't have any major ongoing health conditions?
Are you able to have children (haven't gone through menopause)?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new etonogestrel implant. The study team would track how the hormone from the implant is released into your body over a period of time. This usually involves regular blood tests over several weeks or months to measure the hormone levels. You would also have check-ups to make sure the implant is in place and that you are feeling well.

There would be several visits to the clinic, and depending on the study design, some visits might be longer than others. You would also need to follow specific instructions provided by the study team, such as for food or drink before certain appointments. The total duration of your participation, including all visits and follow-ups, would be explained in full detail by the study team before you decide to join.

Potential risks and benefits

A potential benefit of taking part is contributing to medical research that helps bring new, effective birth control options to others. You would also receive close medical attention and monitoring throughout the study. However, as with any medical procedure, there are potential risks, such as discomfort or bruising when the implant is inserted or removed, or mild side effects from the hormone. The study team would explain all known and possible risks in detail. You are 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
Portugal

Common questions

What is an etonogestrel implant?

It's a small, flexible rod placed under the skin of your upper arm that releases a hormone to prevent pregnancy.

Why is this study being done?

To check if a new version of the etonogestrel implant works in the body in the same way as the one already available.

Will I get paid to participate?

The study team will tell you if any payment or reimbursement for travel is offered.

Is this a new type of birth control?

No, it's a 'new version' of an existing type of birth control implant, aiming to be just as safe and effective.

What if I get pregnant during the study?

The study team will provide detailed information on contraception and procedures if pregnancy occurs.