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AuthorisedTherapeutic use (Phase IV)Interventional

CoCo3 - Comprehensive Health Effects of Combined Contraceptives: a 12-month randomized, controlled, open-label trial of E4+DRSP, EE20μg+DRSP and DRSP-only

This study, called CoCo3, wants to learn more about how different birth control pills affect women's health. It will follow women for 12 months, comparing a newer pill (E4+DRSP) with a commonly used one (EE20μg+DRSP), and a pill that contains only one hormone (DRSP-only). This type of study, often done after a medicine is already available, helps doctors understand how these pills work in real-world use. The main goal is to see if these pills have any health effects, good or bad, over a year.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu
Enrolment target
156
Start
17 Apr 2026

What is this study about?

Imagine you're trying to choose the best birth control pill, and you want to know how it might affect your body over time. That's exactly what this study, called CoCo3, aims to do. It's looking closely at different types of combined contraceptive pills, which contain two main hormones, and one pill that has only one hormone.

The main purpose of the study is to understand the full range of effects these pills have on a woman's health over 12 months. This includes looking at common experiences women have when taking birth control. By comparing how women taking different pills feel and what happens to their bodies, researchers hope to get a clearer picture of how each option works.

This kind of study is often done after a medicine has been approved and is available to the public. It helps gather more information about how the medicines work in a larger group of people and in everyday life. The results could help doctors and women make more informed choices about contraception in the future.

Key takeaways

  • The study explores the effects of different birth control pills on women's health.
  • It lasts for 12 months and involves taking a specific contraceptive pill.
  • Participation includes regular health check-ups and a final visit.
  • It aims to provide more understanding of how these pills work in real-life use.

Who may be eligible?

To be part of this study, you need to be an adult woman, at least 18 years old. There's no upper age limit specified, so if you're over 18, you might be able to join.

Since this study is about contraception, it's open to women who are able to become pregnant and who are considering using or are already using certain types of birth control pills.

There might be other health requirements or reasons why you couldn't join, which a study doctor would discuss with you in full detail. It's always best to talk directly with the study team to find out if it's right 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.

  1. Are you a woman?
  2. Are you 18 years old or older?
  3. Are you considering using or currently using birth control pills?
  4. Are you able to attend regular clinic visits for 12 months?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be asked to take one of the study birth control pills for 12 months. You won't know which specific pill you are taking, as that's decided randomly by the study team. You'll have regular visits to the clinic during this year, where doctors and nurses will check on your health and how you're feeling. There will be a final visit at the end of the 12 months to check your health one last time. The total duration of your active participation, including check-ups, will be about 12 months.

Potential risks and benefits

Taking part in a study like this could help researchers understand more about contraceptive pills, which might benefit future users. However, like any medication, the pills used in this study may have side effects, which the study team will explain fully. You are free 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
    Finland

Common questions

What kind of pills are being studied?

The study looks at different types of birth control pills: a newer combined pill (E4+DRSP), a common combined pill (EE20μg+DRSP), and a pill with only one hormone (DRSP-only).

How long will I be involved in the study?

If you join, you'll be taking the study medication and having health check-ups for about 12 months.

Do I get to choose which pill I take?

No, the specific pill you receive is chosen randomly by the study team to ensure fair comparison between the treatments.

What does a 'Phase IV' study mean?

This means the pills are already approved and available. This phase helps researchers gather more information about how the pills work in many people over time.

Will I have to pay to be in the study?

No, you should not have to pay for any study-related care or medication. Your travel costs for study visits might be reimbursed, but you should confirm this with the study team.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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