Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Brain effects of hormonal contraceptives. A randomized, double-blind, longitudinal study comparing two combined oral contraceptives (Estetrol/drospirenone vs ethinylestradiol/levonorgestrel).

This research study is looking into how two different types of combined hormone birth control pills might affect the brain. The study wants to understand if there are any changes in certain brain areas, like those involved in emotions and thinking, when women take these pills over time. Researchers will compare a newer pill (containing estetrol and drospirenone) with a commonly used pill (containing ethinylestradiol and levonorgestrel). They will also check if these changes relate to improvements in mood, anxiety, and overall quality of life. This is a "Phase IV" study, meaning it's looking at treatments already approved and used, to learn more about them with real-world use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Region Uppsala

Enrolment target

Start

18 Jan 2024

Contraception

What is this study about?

This study is investigating something very interesting: how hormone birth control pills might affect the brain. We know these pills are very effective at preventing pregnancy, but researchers want to understand if they also have an impact on brain structure and how the brain works, especially concerning emotions.

The study will look at two different types of combined oral contraceptive pills. One is a newer pill that contains two hormones called estetrol and drospirenone. The other is a well-known pill that contains hormones called ethinylestradiol and levonorgestrel. By comparing these two, scientists hope to learn if different hormone combinations have different effects on the brain.

In simple terms, they will be using special brain scans to measure things like the size of certain brain parts, how brain connections are formed, and how the brain reacts when processing emotions. They will take measurements at the start and again after women have been taking the pill for a while. They will also ask about mood (like feelings of sadness or worry) and general well-being to see if these brain changes connect with how women feel in their daily lives.

Key takeaways

This study explores how two common birth control pills affect the brain.
It aims to understand if different pills impact brain structure and emotional responses.
Brain scans and mood questionnaires will be used to gather information.
Participation helps future understanding of hormone contraceptives.
It's for women aged 18 and over who use or plan to use combined oral contraceptives.

Who may be eligible?

This study is open to women who are at least 18 years old. There is no upper age limit for taking part.

To be eligible, you will need to be a woman who is currently able to become pregnant and is considering starting or switching to one of the birth control pills being studied.

More specific details about your health, any medications you are taking, or pre-existing conditions would be discussed with the study team to ensure this study is right and safe for you.

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 18 years old or older?
Are you a woman?
Are you currently thinking about starting or switching to a combined hormone birth control pill?
Are you comfortable having brain scans (like an MRI)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'd likely have a few visits to the study clinic. At the very beginning, you would have a health check-up and some brain scans or tests to get a 'baseline' measurement – this is what you're like before starting the pill. Then, you would start taking one of the study birth control pills, which would be given to you by the research team. Over an agreed period, you'd come back for follow-up visits. During these visits, the team would repeat some of the brain scans and tests, and you'd also fill out questionnaires about your mood, how you're feeling, and your general quality of life. The exact number of visits and the total time taking part would be explained fully by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your involvement will help scientists understand more about how birth control pills affect the brain, which could help many women in the future. As with any medication, there are potential side effects from the birth control pills themselves. The study team will explain these thoroughly, and you would be carefully monitored. You have the right to leave 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
Sweden

Common questions

What kind of birth control pills are being studied?

The study is looking at two types of combined hormone birth control pills: one with estetrol and drospirenone, and another with ethinylestradiol and levonorgestrel.

Will I know which pill I'm taking?

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know which of the two pills you are taking. This helps make the study results fairer.

What will happen during the brain scans?

You'll have special types of scans, like MRI, which use magnets and radio waves to create detailed pictures of your brain. These scans are safe and don't involve radiation.

How long will I be in the study?

The exact duration will be explained by the study team, but it involves taking the pill for a period and having follow-up appointments to see changes over time.

Will this study help me personally?

While you might not personally benefit, your participation will provide important information that could help improve our understanding of hormone contraceptives for all women in the future.