A study comparing the effects of estetrol and drospirenone, ethinylestradiol and drospirenone, and drospirenone in women with polycystic ovary syndrome (PCOS)

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What is this study about?

This study focuses on women with Polycystic Ovary Syndrome, a condition that affects hormone levels. The purpose of the study is to investigate how different types of contraception, which are methods used to prevent pregnancy, affect blood clotting. Participants will be assigned to use different medications taken by mouth, including estetrol and drospirenone, ethinylestradiol and drospirenone, or only drospirenone.

During the trial, individuals will take one of the three different medication combinations for a period of six months. The study will look at how these treatments impact coagulation, which is the process the body uses to form clots in the blood. By comparing these options, researchers aim to see if certain hormone combinations have a smaller effect on the blood’s ability to clot compared to others.

Who Can Join the Study?

You must be a female between the ages of 18 and 40 when you start the study.
You must be willing to take the study medication and sign a written informed consent, which is a formal document where you agree to participate after being told about the study details.
Your BMI (Body Mass Index, a measure of body fat based on your height and weight) must be between 18 and 29.9 kg/m2.
You must have been diagnosed with PCOS (Polycystic Ovary Syndrome, a condition that affects hormone levels in women) based on specific medical rules called the Rotterdam criteria. This means you must show signs of hyperandrogenism (excess male-type hormones), PCOM (the presence of small cysts on the ovaries seen on an ultrasound), or menstrual irregularities (unpredictable or irregular periods).
Aside from PCOS, you must be healthy with no other significant illnesses or ongoing medical treatments.
You must have stopped using hormonal contraceptive medication (birth control) at least two months before the study begins.
It must have been at least three months since your last pregnancy or since you finished breastfeeding.
You must have enough knowledge of Finnish to read the study documents and talk to the research team.

Who Cannot Join the Study?

You have a medical reason why you cannot use combined contraceptives, which are birth control methods that use more than one type of hormone.
You have any clinically significant abnormalities, which means important or concerning health issues, found during your medical tests or ultrasound (a way to see inside the body using sound waves).
You are a regular smoker, use nicotine products (such as patches or gum), use illegal drugs, or have a problem with alcohol abuse.
You are planning to become pregnant while participating in this study.
You have any disease or condition that could make it difficult to complete the study or could make the results of the study difficult to understand.

Where you can join this trial?

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Site Name	City	Country	Status
Umqnwojbjj Od Ohhj	Oulu	Finland
Hakrmuop Uqxifeagsc Cqghacs Hbfoybio	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.02.2026

Trial locations

Investigated drugs:

Drovelis is a combined hormonal contraceptive pill that contains two types of hormones, estetrol and drospirenone, taken orally to prevent pregnancy.

Slinda is a hormonal contraceptive pill containing only drospirenone, taken orally to prevent pregnancy.

Daylette is a combined hormonal contraceptive pill that contains two types of hormones, ethinylestradiol and drospirenone, taken orally to prevent pregnancy.

Contraception – This refers to the use of various methods or substances to prevent pregnancy. It involves processes that stop the release of eggs from the ovaries or prevent a fertilized egg from attaching to the uterus. These methods can be used temporarily or long-term to manage reproductive functions. The effectiveness depends on how the substances interact with the body’s natural hormonal cycles.

Trial ID:

2025-523358-15-00

Protocol code:

CoCo3-PCOS

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study comparing the effects of estetrol and drospirenone, ethinylestradiol and drospirenone, and drospirenone in women with polycystic ovary syndrome (PCOS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?