Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Testosterone Transdermal Gel in Healthy Female Participants.

This study is about a testosterone gel designed for women. Researchers want to see if a new version of this gel works in the same way as an existing one. They will check how much of the gel's active ingredient gets into the body and how long it stays there. This is called a 'bioequivalence' study. It helps make sure that a new version of a medicine will have the same effects as an older, approved one. The study is open to healthy women aged 18 and over who do not have any existing medical conditions. Taking part would involve some visits and checks to understand how the gel is absorbed.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

04 Nov 2025

No medical conditions.

What is this study about?

Imagine you have a common medicine, like a painkiller. Sometimes, a different company might want to make their own version of that medicine. Before they can sell it, they need to prove that their version works just as well as the original. This is exactly what this study is trying to do, but for a special testosterone gel for women.

Testosterone is a hormone that women naturally produce, although in much smaller amounts than men. It's important for various body functions, including bone health, energy, and mood. For some women, especially after menopause or certain medical treatments, testosterone levels can become low, which can impact their well-being. Gels are one way to give the body more of this hormone.

This study is a 'Phase I' trial, which means it's one of the first human studies for this specific product. Researchers are focusing on something called 'bioequivalence.' This simply means they want to make sure that the new testosterone gel is absorbed into the body in the same way, and at similar levels, as a testosterone gel that is already approved and known to be effective. It's a crucial step to ensure that any new version of the gel would be safe and work as expected for women who might need it.

Key takeaways

This study is testing a new testosterone gel for women.
It's comparing how a new gel works with an existing one.
Only healthy women, aged 18 and over, can take part.
The study involves clinic visits and blood tests.
The aim is to ensure new gels are safe and effective.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for healthy women to take part. To be considered, you must not have any long-term medical conditions or serious health problems. The researchers want to make sure that any results they get are purely from the gel and not affected by other health issues.

You also need to be at least 18 years old to join this study. There is no upper age limit, so as long as you are a healthy adult woman, you can be considered.

Because this study is specifically about how a new testosterone gel designed for women works, it is only open to female participants.

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 female?
Are you 18 years old or older?
Are you generally healthy with no serious existing medical conditions?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to a clinic. During these visits, nurses or doctors would give you the testosterone gel to apply. They would then take regular blood samples over a set period to measure how much of the gel's active ingredient is in your body and how it's being absorbed. You might also have other health checks, like blood pressure and heart rate measurements.

The study would involve a specific schedule for applying the gel and for your clinic visits. The total duration of your involvement could range from a few weeks to a couple of months, depending on the exact design of the study. You would be given clear instructions on how to use the gel and what to expect at each appointment. There would also be follow-up calls or visits to ensure your well-being after you have completed the main part of the study.

Potential risks and benefits

Taking part in a study like this could offer some benefits, such as contributing to medical knowledge that might help other women in the future. You would also receive regular health checks during the study. However, there are potential risks, including side effects from the gel (which could be mild, like skin irritation where applied, or more general, like changes in mood or energy), discomfort from blood tests, or inconvenience from the clinic visits. You should know that you can choose to leave 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 testosterone gel used for in women?

In women, testosterone gel might be used to help with symptoms of low testosterone, which can include low energy, reduced sex drive, or mood changes. It's not commonly prescribed but can be helpful for some.

What does a 'bioequivalence' study mean?

It means the study is comparing a new version of a medicine to an existing one. The goal is to show that both versions act the same way in the body – meaning they are absorbed at similar rates and amounts.

Will I receive treatment for a medical condition in this study?

No, this study is for healthy women and is not designed to treat any medical conditions. It’s purely to understand how the new gel is absorbed by the body.

Are there any costs involved for me if I participate?

Typically, participants do not pay to be in clinical trials. Sometimes, expenses like travel or time might be covered or reimbursed, but this would be explained fully.

What happens to my personal information if I join?

Your personal information would be kept confidential. Researchers use coded data to protect your identity, meaning your name won't be directly linked to your study results.