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 a birth control implant that contains the medicine etonogestrel. The main goal is to check if this new implant delivers the medicine into the body in the same way as the current, well-known implant does. This is called a 'bioequivalence' study. It's for healthy women who have not yet reached menopause and are not currently pregnant. By making sure different versions of the same medicine work identically, doctors can be confident that patients will receive the same safe and effective treatment, no matter which version they are given. This study is an important step in making sure new medicines are just as reliable as old ones.

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?

Imagine you have a headache and take a painkiller. If a different company makes the same painkiller, you’d want to be sure it works just as well. This is what this study is about, but for a birth control implant. Birth control implants are small, flexible rods placed under the skin of your arm that slowly release a hormone to prevent pregnancy. The hormone is called etonogestrel.

Researchers are looking at a new version of an etonogestrel implant. They want to check if this new version releases the hormone into the body in exactly the same way as the already approved and commonly used implant. This type of study is called a ‘bioequivalence’ study. It’s an important early step in testing new medicines or new ways to deliver existing medicines.

The main reason for this study is to make sure that if this new implant is approved, it will be just as safe and effective as the current one. It helps doctors and patients know that they can expect the same reliable results, no matter which version of the implant they use. This helps to ensure that all birth control options available are trustworthy and work as expected.

Key takeaways

This study compares a new birth control implant to an existing one.
It aims to ensure the new implant works exactly the same way.
It's for healthy women who are not pregnant and haven't reached menopause.
Participation involves receiving the implant and having regular check-ups.
There are no direct personal health benefits from joining.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy women to take part. You need to be between 18 years old and the age when most women go through menopause (this can vary, but generally before your late 40s or early 50s).

It’s important that you have not yet reached menopause. Also, you must not be pregnant when you join the study. The study is specifically for women who are generally well and don't have any serious health problems.

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?
Have you not yet gone through menopause?
Are you not currently pregnant?
Are you generally healthy with no major medical conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the etonogestrel implant. Researchers would then regularly check the levels of the medicine in your body, usually through blood tests over a certain period. The study will involve several visits to the clinic, where you might have physical check-ups and provide blood samples. The total duration of your participation, from receiving the implant to the final follow-up tests, would be explained to you in detail by the study team.

Potential risks and benefits

Potential benefits may include contributing to medical science and helping to ensure new treatments are safe and effective for future patients. However, there are no direct health benefits for participants. Potential risks are generally mild, such as discomfort or bruising from blood tests or from getting the implant inserted or removed. More serious risks are rare but always explained thoroughly. You have the right 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 'bioequivalence'?

It means researchers are checking if a new version of a medicine works exactly the same in your body as an existing, approved version.

What is etonogestrel?

Etonogestrel is a hormone used in some birth control methods, like implants, to prevent pregnancy.

Who is paying for this study?

This information isn't given in the summary, but the study team can tell you who is funding the research.

Will I get paid to participate?

Sometimes studies offer compensation for your time and travel. Ask the study team about this.

What if I get pregnant during the study?

If you are considering joining, you should discuss birth control methods with the study team to prevent pregnancy during the study, as it's for non-pregnant women.