Evaluation of the bioavailability of two transdermal gel preparations containing 0.1% w/w estradiol under fasting conditions: Estradiol/INTERMED gel 0.1% w/w (Test) vs. ESTREVA® 0.1%, gel (Comparator). A monocentric, open, randomized, single dose, two-period, crossover trial in healthy postmenopausal women
This study is looking at two different oestrogen gels that women might use after menopause. The main goal is to compare how much of the oestrogen from a new gel, called Estradiol/INTERMED, gets into the body compared to a widely used gel called ESTREVA®. This is important because it helps scientists understand if the new gel works in a similar way to the well-known one when applied to the skin. Healthy women who have gone through menopause will be involved in this trial. They will try each gel at different times to see how the body absorbs them when they haven't eaten beforehand. This type of study is an early step in checking if a new medicine works as expected.
At a glance
What is this study about?
This research is focused on two gels that contain oestrogen, a hormone that often decreases after menopause. One gel is a new option called Estradiol/INTERMED, and the other is an existing gel called ESTREVA®. The main purpose of this study is to compare how much oestrogen from each gel gets into a woman's body after it's applied to the skin. This information helps us understand if the new gel is absorbed in a similar way to the established medicine.
Think of it like this: when you take a medicine, your body needs to absorb it for it to work. For a gel applied to the skin, we want to know how much of the active ingredient (oestrogen in this case) actually passes through the skin and enters the bloodstream. This particular study is designed to be a very careful comparison. Participants will try each gel at different times, and scientists will closely monitor the levels of oestrogen in their bodies.
This study is an early-stage trial, often called a 'Phase I' study. This means it's not looking to treat a specific illness. Instead, it's about understanding how the gels interact with the body in healthy individuals. The results will provide important information for potentially developing the new gel further, helping to ensure that future treatments are effective and safe.
Key takeaways
- Compares how two oestrogen gels are absorbed by the body.
- Specifically for healthy women who have gone through menopause.
- Requires two clinic visits where you’ll try each gel.
- You’ll need to fast before applying the gel on study days.
- Helps scientists understand an early stage of medicine development.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is specifically looking for women who have gone through menopause and are generally healthy. You need to be at least 18 years old to take part, and there's no upper age limit specified, as long as you meet the other health requirements.
Since this is an early study, participants need to be healthy volunteers. This means the researchers are not looking for people with specific health conditions to treat. They want to understand how the gels work in a body that isn't dealing with other health problems that might affect the results.
More detailed health checks will be done by the study team to make sure it's safe for you to participate and that your health won't affect the study results. They will explain all the criteria fully before you decide to join.
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?
- Have you gone through menopause?
- Are you at least 18 years old?
- Are you generally healthy, without significant long-term health conditions?
- Are you willing to fast before gel application on study days?
- Are you able to attend two study visits?
What does participation involve?
If you join this study, you'll be asked to visit the study clinic two times. On each visit, you will try one of the two oestrogen gels. Your visits will be separated by a short break, meaning you won't use both gels at the same time. Before applying the gel, you'll need to fast, which means not eating for a certain period, usually overnight, to ensure consistent results. After applying the gel, the study team will take blood samples regularly to measure how much oestrogen has entered your bloodstream. You might also have other health checks during your visits, such as measuring your blood pressure. The total time you'll be involved in the study, from your first visit to your last follow-up, will be relatively short, likely a few weeks, though specific timings will be explained.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is oestrogen gel used for?
Oestrogen gels are often used by women after menopause to help with symptoms like hot flushes or to replace a drop in hormone levels.
Why do I need to fast before applying the gel?
Fasting helps make sure that food doesn't affect how the gel is absorbed into your body, making the study results more accurate.
Will this study treat any of my health problems?
No, this study is not designed to treat any medical conditions. It's an early study to understand how different gels are absorbed in healthy women.
How long will I be in the study?
The study involves two visits to the clinic, separated by a break. The total time you spend participating will be explained to you in detail by the study team.
Can I stop participating if I change my mind?
Yes, you can choose to leave the study at any point, and you don't need to give a reason. Your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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