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 68 mg implant, which is a contraceptive (birth control) device. The main goal is to make sure this new implant works just as well and safely releases the hormone as the original one that's already available. This type of study, often called a bioequivalence study, is a standard part of developing new medicines or medical devices to ensure they are identical to existing, approved ones. It's for healthy women who are able to get pregnant but are not currently pregnant. Participants will receive the implant and be carefully monitored to see how their bodies handle the hormone.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

11 Apr 2025

No medical condition.

What is this study about?

This research study is about a type of birth control called the Etonogestrel 68 mg implant. This implant is a small, flexible rod placed under the skin of your upper arm, which slowly releases a hormone to prevent pregnancy for up to three years. The study is particularly interested in a *new version* of this implant.

The main purpose of this study is to check if this new version of the Etonogestrel implant works in the same way as the original one that's already been approved for use. This is very important because it helps ensure that any new medicine or medical device is just as effective and safe as the one it's based on. Scientists call this a 'bioequivalence' study, meaning they are comparing how well the body absorbs and uses the hormone from both products to make sure they are equivalent.

By taking part, you would be helping researchers confirm the new implant is just as reliable for contraception. Studies like this are a vital step before any new version of a medicine or device can be made widely available to patients. It helps make sure that people have access to safe and effective birth control options.

Key takeaways

This study is testing a new version of an implantable birth control device.
It aims to confirm the new implant works the same as the original.
It's for healthy women aged 18 and over who are not pregnant.
Participation involves receiving the implant and attending follow-up visits.
You would contribute to ensuring new contraceptive options are safe and effective.

Who may be eligible?

To be considered for this study, you need to be a healthy woman. You should be able to get pregnant, meaning you haven't gone through menopause or had a procedure that would prevent you from getting pregnant, like a hysterectomy.

It's very important that you are not pregnant when you join the study. The study team will do tests to confirm this. You also need to be at least 18 years old. There isn't an upper age limit mentioned, as long as you meet the other health and pregnancy criteria.

Because this study is looking at an implant that prevents pregnancy, it's specifically for women. If you have any serious health conditions, particularly ones that might affect how your body handles medicines or hormones, you might not be suitable for this study.

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 currently not pregnant?
Are you able to get pregnant (e.g., not post-menopause or had a hysterectomy)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive the Etonogestrel 68 mg implant. The study team will need to assess your health at the beginning, likely including blood tests and a pregnancy test, to make sure it's safe for you to participate. You would then have the implant inserted, which is a quick procedure usually done with a local anaesthetic to numb your arm.

After the implant is inserted, you would have a series of follow-up visits to the clinic. During these visits, the study team would check your health, ask about any side effects, and likely take blood samples. These blood samples help the researchers understand how the hormone is being released from the implant into your body over time. The exact number and frequency of visits, as well as the total duration of your participation, would be explained in full detail by the study team.

Potential risks and benefits

Taking part in this study could mean you are among the first to use a new version of an established contraceptive implant, contributing to medical science. However, as with any medical procedure or medication, there are potential risks. These could include minor pain or bruising at the implant site, changes in your menstrual bleeding pattern, or other side effects associated with Etonogestrel, similar to those experienced with the original implant. Serious side effects are rare but possible. You will be given a complete list of potential side effects and risks by the study team. Remember, 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?

Bioequivalence means that a new medicine or device works in the same way and releases the active ingredient (like a hormone) into the body in the same amount and at the same speed as an existing, approved one.

Will this implant prevent pregnancy?

Yes, the Etonogestrel implant is designed to prevent pregnancy. However, in this study, researchers are checking if the new version works just as effectively as the original.

Do I have to stop my current birth control if I join?

Yes, you would need to switch to the study's implant. The study team will provide guidance on how to safely transition from any current birth control.

What if I experience side effects?

The study team will carefully monitor you for any side effects and provide guidance and care if you experience any. It's important to tell them about anything you feel.

Will I be paid to take part?

Studies sometimes offer payment to cover your time and travel, but this varies. You should ask the study team if this is the case for this particular trial.