Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Multiple-Ascending Doses of 2-Methoxyestradiol in Healthy Non-Pregnant Female Participants.

This research study is looking for healthy women to help test a new medicine called 2-Methoxyestradiol. This is a very early-stage study, often called a Phase 1 trial. Its main goal is to understand how the medicine behaves in the body, such as how it's absorbed, distributed, and eventually leaves the system. Researchers also want to find out if it's safe and well-tolerated at different dose levels. Because it's an early safety study, participants will be healthy, meaning they don't have any medical conditions that are being treated by the new medicine. This kind of research is crucial for developing new treatments in the future, even if the medicine itself isn't treating a specific illness in this trial.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Laboratorios Leon Farma S.A.

Enrolment target

Start

29 Sep 2025

No medical condition.

What is this study about?

This study is an early research step to learn more about a new medicine called 2-Methoxyestradiol. It’s often called a ‘Phase 1’ study, which means it’s one of the first times this medicine is being given to people. The main goals are to check if the medicine is safe when given at different doses and to understand how it acts in the human body – for example, how much enters the bloodstream, how long it stays there, and how it’s eventually cleared out.

Because safety is the top priority at this stage, the study is inviting women who are generally healthy and don't have any medical conditions. This allows the researchers to see the effects of the new medicine clearly, without other health problems complicating the results. It's important to remember that this study isn't designed to treat a specific illness; instead, it's about gathering fundamental information about the medicine itself.

The information gathered from studies like this is really important for future medicine development. Understanding how a new medicine works in healthy people helps scientists decide if it's safe and effective enough to move on to later stages of testing, where it might be given to patients with particular health conditions. Every new medicine that gets approved for use has to go through these careful, step-by-step studies to ensure it's as safe and helpful as possible.

Key takeaways

This is a very early-stage study (Phase 1) for a new medicine.
It aims to find out if the medicine, 2-Methoxyestradiol, is safe and how it works in the body.
Only healthy women, aged 18 and over, can take part.
Participants will receive increasing doses and be closely monitored.
Taking part helps future medicine development but won't directly treat an illness you might have.
You can stop participating at any time.

Who may be eligible?

To join this study, we are looking for women who are 18 years old or older. There is no upper age limit, meaning older women can also take part.

It’s really important that you are in good general health. This means you shouldn't have any ongoing medical conditions or be pregnant. The study needs healthy volunteers so the researchers can properly see how the new medicine affects the body without other health issues getting in the way.

Also, because this medicine's name includes 'estradiol,' which is related to female hormones, the study is specifically for women.

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 not pregnant or planning to become pregnant during the study?
Are you not currently taking other medicines that might interfere with the study drug?
Do you understand this study is not for treating an illness?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive doses of the study medicine, 2-Methoxyestradiol, which would be given in increasing amounts over time (multiple-ascending doses). This means you might start with a low dose, and if it's safe, you might receive a slightly higher dose later. You would likely have several visits to a clinic or research centre. During these visits, the research team would monitor your health closely. This would involve regular check-ups, blood tests, and possibly other tests to see how the medicine is affecting your body and to make sure you are feeling well. The total duration of your participation would depend on the specific schedule of doses and follow-up visits, but as it's a Phase 1 study, it could last several weeks to a few months.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health as it's not a treatment for an existing condition. However, you would be contributing valuable information that helps medical science develop new medicines for the future, which can ultimately benefit many people. As with any medicine, there's always a possibility of experiencing side effects, some of which might not be known yet. The research team will monitor you very closely for any changes in your health. You would also be fully informed about any known potential risks and 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.

—
Unverified
Portugal

Common questions

What is 2-Methoxyestradiol?

It's a new medicine being studied. In this trial, researchers are trying to understand how it works and if it's safe, not to treat a specific illness.

Why are only women being asked to join?

The medicine's name, 'estradiol,' suggests it might be related to female hormones, so the study is specifically focusing on women for this early research.

Do I need to have a specific illness to join?

No, quite the opposite. This study is looking for healthy women, without any medical conditions, to learn about the new medicine's basic effects.

Will this medicine cure anything?

This early study is not designed to cure anything. Its purpose is to check safety and how the medicine acts in the body, which helps future research.

What does 'multiple-ascending doses' mean?

It means participants might receive several doses, starting low and potentially increasing over time, so researchers can see how different amounts affect the body.