Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Comparative Bioavailability and Bioequivalence of Testosterone Transdermal Gel Versus Testogel® Dosiergel 16.2 mg/g gel: A Single-Dose, Open-Label, Randomized, Full Replicate, Four-Period Crossover Study in Healthy Female Subjects Under Fasting Conditions.

This research study is looking at a new testosterone gel and comparing it to an already approved one called Testogel. The main goal is to check if these two gels deliver the same amount of testosterone into the body. This is important for ensuring that new medications work in a similar and effective way to existing ones. This early stage study involves healthy women and is designed to compare how the body takes in and uses the testosterone from each gel. This information helps us understand if the new gel could be a good treatment option for men who have low testosterone levels.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

30 Jan 2023

Male hypogonadism

What is this study about?

Imagine your body needs a certain amount of a hormone like testosterone. Sometimes, for different reasons, men can have too little testosterone. Doctors might prescribe a gel that you rub on your skin to help bring those levels up. This study is like a 'twin test' for a new testosterone gel and one that's already being used.

We want to see if the new gel works just as well as the existing Testogel. This means checking if your body absorbs the same amount of testosterone from both gels and if it stays in your system for a similar amount of time. Even though testosterone is often associated with men, this particular study is being done in healthy women. This is a common and safe way to test how medications are absorbed by the body in these early stages, before they are given to patients they are intended for.

By understanding how these gels are taken up by the body, we can make sure that if the new gel is eventually approved for use, it will be an effective and reliable treatment option for men who need it. This kind of research is a vital step in developing new medicines.

Key takeaways

Compares a new testosterone gel to an existing one.
Aims to check if both gels deliver similar amounts of testosterone.
Involves healthy women aged 18 and over.
Requires clinic visits for blood tests and health checks.
Helps develop safe and effective medicines for men with low testosterone.

Who may be eligible?

To join this study, you must be a woman aged 18 years or older. This study is specifically designed for healthy women to help us understand how the gels are absorbed by the body.

You should generally be in good health. The medical team will check this with examinations and 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 in good health?
Are you able to attend several clinic visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given both the new testosterone gel and the existing Testogel at different times. It's like comparing them back-to-back. You'll switch between the gels after a break. This is a 'crossover' study, meaning everyone tries both treatments.

During your time in the study, you'll have several visits to the clinic. These visits will involve blood tests to measure the testosterone levels in your body. We'll also do some checks to make sure you're healthy throughout the study, such as physical exams, skin checks, and heart tests (like an ECG). We'll also keep a close eye on any side effects you might experience. The total duration of your participation will involve a few periods of taking the gel and follow-up assessments.

Potential risks and benefits

Participating in this study might offer some potential personal benefits, such as receiving health checks and contributing to medical research. However, the main benefit is for future patients, as your participation helps us learn more about new medicines. Every medication carries some potential risks, such as skin irritation where the gel is applied, or other side effects, which will be carefully monitored. 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 the main goal of this study?

The main goal is to see if a new testosterone gel delivers the same amount of testosterone into the body as an existing one, Testogel.

Why are healthy women taking part if the gel is for men?

Using healthy women allows us to safely and clearly understand how the body absorbs the gels in these early stages of research.

What kind of tests will I have?

You'll have blood tests, physical exams, skin checks, heart tests (ECG), and we'll monitor your overall health and any side effects.

Will I receive treatment for low testosterone?

No, this study is about comparing how the gels work, not treating a condition in participants. It's for research purposes only.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect any future medical care.