Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study looking into the effect of NNC05190130 on blood levels of a birth control pill and emptying of the stomach in women after menopause

This research study is for healthy women who have finished menopause. Scientists want to understand how a new investigational medication, called NNC05190130, interacts with birth control pills in the body. They are also looking at how this new medicine affects the speed at which food empties from the stomach. This is an early stage of research, sometimes called a Phase 1 study, which helps doctors learn more about how a new medicine works in people. It's important for understanding potential effects and interactions before the medicine is tested in larger groups. The study helps ensure new treatments are safe and work as expected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

27 Jun 2024

Healthy postmenopausal females (Type 2 Diabetes)

What is this study about?

This study is designed for healthy women who have already gone through menopause. Researchers are interested in a new medication, which for now is just known by a code, NNC05190130. They want to see how this medicine might affect how birth control pills work in the body – specifically, how much of the birth control medicine stays in your blood. This is important because if a new medicine changes how another medicine works, it could make it more or less effective.

The study also looks at how NNC05190130 affects how quickly food moves from your stomach into your intestines. This is often called 'stomach emptying.' This can be important because it can influence how other medicines are absorbed into your body, and it can also affect your digestion and how you feel after eating.

This is an early stage of research, sometimes called a 'Phase 1' study. In this type of study, researchers are mainly focused on understanding how a new medicine behaves in people – how it's absorbed, where it goes in the body, and how the body gets rid of it. They also look closely at any side effects. Studies like this are a really important step in developing new medicines, helping doctors make sure they are safe and predictable before they are given to more patients.

Key takeaways

Study for healthy women past menopause.
Investigates a new medicine (NNC05190130).
Looks at how it affects birth control pills and stomach emptying.
It's an early-stage (Phase 1) study.
Helps understand new medicines and their interactions.

Who may be eligible?

This study is looking for healthy women who have finished menopause. This means you are no longer having menstrual periods.

You should be at least 18 years old to take part. There is no upper age limit, so older women who meet the health criteria can also be considered.

Even though the 'conditions' section mentions Type 2 Diabetes, the main eligibility states 'healthy postmenopausal females.' This suggests that while researchers might be interested in a specific aspect related to Type 2 Diabetes later, for this particular early-stage study, participants need to be generally healthy and not have ongoing health problems that could affect the study results.

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 (no periods for at least 12 months)?
Are you generally healthy?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

While the detailed description isn't available, early-stage studies like this usually involve several visits to a clinic. You would likely be given the new medicine, NNC05190130, and possibly a birth control pill, and have blood samples taken regularly to check medicine levels. You might also have tests to measure your stomach emptying, which could involve special meals or imaging scans. The total duration of your participation could range from a few days to several weeks, depending on the number of doses and follow-up tests required. You will be monitored closely by medical staff throughout your participation.

Potential risks and benefits

Taking part in a study like this might not offer a direct health benefit to you, but you would be helping advance medical knowledge, which could benefit others in the future. As with any new medicine, there's always a chance of unknown side effects, even in an early-stage study. Medical staff will monitor you carefully for any problems, and 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
Germany

Common questions

What does 'postmenopausal' mean?

It means you have completely stopped having your monthly periods due to a natural change in your body, and it's been at least 12 months since your last period.

Will I be paid to take part?

Often, early-stage studies like this offer payment for your time and travel, but you would need to ask the study team for details.

What is a 'Phase 1' study?

It's the very first stage where a new medicine is given to people. It's mainly to see if it's safe and how it acts in the body, not to see if it treats a specific illness.

Do I need to have Type 2 Diabetes to join?

The study states it's for 'healthy postmenopausal females'. While Type 2 Diabetes is mentioned, for this early phase, the priority is generally healthy volunteers. You'd need to confirm with the study team if having Type 2 Diabetes would make you ineligible or if there’s a specific interest in that group for other reasons.

Will I still be able to take my regular medicines?

You must tell the study team about all medicines you take, including over-the-counter ones. They will tell you if any need to be stopped or changed for the study.