AuthorisedTherapeutic use (Phase IV)Interventional

CoCo-PCOS - Comprehensive Health Effects of Combined Contraceptives: a 6-month randomized, controlled, open-label trial of E4+DRSP, EE20µg+DRSP, and DRSP-only in women with PCOS

This study, called CoCo-PCOS, is looking into how different types of contraception affect the health of women who have Polycystic Ovary Syndrome (PCOS). Researchers want to understand the full health effects, beyond just preventing pregnancy. For six months, women will take one of three common birth control pills. The main aim is to compare these different medicines to see how they impact various aspects of health in women with PCOS. It's a real-world study, gathering information on how these widely used treatments work in practice for this specific group of women.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu

Enrolment target

156

Start

20 Apr 2026

Contraception

What is this study about?

This study, known as CoCo-PCOS, is designed to understand more about how different types of combined contraceptive pills, often called "the pill," affect women who have Polycystic Ovary Syndrome, or PCOS. PCOS is a common condition that can affect a woman's periods, fertility, hormones, and appearance. Many women with PCOS are prescribed birth control pills not just for contraception, but also to help manage their symptoms.

In this research, doctors are comparing three different types of birth control pills that are already available and commonly used. They want to see how each of these specific medications impacts the overall health of women with PCOS over a six-month period. This includes looking at various health factors that might be important for women with PCOS, beyond just their ability to prevent pregnancy.

The main goal is to gather detailed information on how these common treatments work in real-life situations for women with PCOS. By doing this, researchers hope to better understand the benefits and potential effects of these different pills, which could lead to better guidance for doctors and women with PCOS in the future when choosing the most suitable treatment.

Key takeaways

Studies how birth control pills affect women with PCOS.
Uses commonly available birth control medications.
Participation lasts for six months.
Aims to understand full health effects, not just contraception.
Could help improve future treatment choices for PCOS.

Who may be eligible?

To be considered for this study, you must be a woman aged 18 years or older. There is no upper age limit, meaning any adult woman can potentially take part as long as she meets the other criteria.

Critically, you must have Polycystic Ovary Syndrome (PCOS) to be eligible for this study, as the research specifically focuses on how these medications affect women with this condition. You would also need to be suitable and willing to take one of the study medications, which are forms of birth control pills.

As this study is looking at contraceptive use, you would likely need to be someone who would normally consider using birth control or for whom a doctor would recommend it for managing PCOS symptoms. The study will confirm specific medical details to ensure it's safe for you to participate.

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 female?
Are you 18 years old or older?
Have you been diagnosed with Polycystic Ovary Syndrome (PCOS)?
Are you willing to take a birth control pill for six months?
Are you able to attend regular study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to take one of the assigned study medications (a birth control pill) for a period of six months. This would involve taking your pill as directed each day.

Throughout the six months, you would have some study visits, including an initial screening visit to ensure you're a good fit, and then follow-up visits to check on your health and how you're reacting to the medication. At the very end of the six months, you would have a final follow-up visit, which is called the 'endpoint visit', to assess all the study findings. The full duration of your active involvement in the study would be approximately six months, after which your participation would conclude.

Potential risks and benefits

Participating in this study might offer a benefit by giving you access to closely monitored care and one of the commonly prescribed treatments for PCOS. You would also be contributing to important scientific knowledge that could help other women with PCOS in the future. As with all medications, there's a possibility of side effects from the study treatments, which are types of birth control pills; these will be fully explained to you before you agree to take part. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Finland

Common questions

What is PCOS?

PCOS stands for Polycystic Ovary Syndrome, a common hormone condition in women that can cause irregular periods, acne, and other symptoms.

Are the medications new or experimental?

No, the medications used in this study are already approved and commonly prescribed types of birth control pills. This study looks at how they work in real life for women with PCOS.

Why are different pills being compared?

Researchers want to see if specific types of birth control pills have different effects on the overall health of women with PCOS, helping doctors choose the best option.

How long does the study last?

If you participate, you will take the study medication for six months, with a final check-up at the end.

Do I have to stop my current treatments?

The study team will discuss all your current medications and health plans with you to see if you can safely participate.