Study on the Effects of Hormonal Contraceptives on the Brain: Comparing Drospirenone and Estetrol with Ethinylestradiol and Levonorgestrel in Women Using Contraception

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What is this study about?

This clinical trial is focused on studying the effects of hormonal contraceptives on the brain. The study involves two types of combined oral contraceptives: one containing estetrol and drospirenone, and the other containing ethinylestradiol and levonorgestrel. These medications are commonly used for contraception, which is the prevention of pregnancy.

The purpose of the study is to determine if these contraceptives have different effects on the brain’s structure and function. Participants will be randomly assigned to take one of the two contraceptives or a placebo. The study will observe changes in the brain over time, focusing on areas such as grey matter, which is involved in processing information, and white matter, which connects different parts of the brain. The study will also look at how the brain responds when processing emotions.

Participants will be involved in the study for up to 12 months. During this time, they will undergo various assessments to monitor changes in their brain and overall well-being. The study will also evaluate changes in mood and quality of life. This research aims to provide a better understanding of how hormonal contraceptives might influence brain health and emotional well-being.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as being a woman aged 18-35, having a regular menstrual cycle, and being in need of contraception.

You will be informed about the study’s purpose, which is to understand the effects of two types of hormonal contraceptives on brain structure and function.

2 randomization

You will be randomly assigned to one of two groups. One group will receive a combined oral contraceptive containing estetrol and drospirenone, while the other group will receive a contraceptive containing ethinylestradiol and levonorgestrel.

This process is double-blind, meaning neither you nor the researchers will know which group you are in.

3 medication administration

You will take the assigned contraceptive pill orally once a day. The duration of the medication administration will be specified by the study protocol.

It is important to take the medication consistently at the same time each day to ensure accurate results.

4 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits will monitor any changes in your health and assess the effects of the contraceptive on your brain structure and function.

During these visits, various assessments will be conducted, including evaluations of your emotional processing and quality of life.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate any changes from the beginning of the study.

This assessment will include a review of your overall health, brain imaging results, and any changes in mood or anxiety levels.

Who Can Join the Study?

Must be essentially healthy.
Must be in need of contraception, meaning you are sexually active and want to prevent pregnancy.
Must be a woman between 18-35 years of age (18 years or older and younger than 36 years).
Must have a regular menstrual cycle, which means your period comes every 25 to 31 days, as determined by the study doctor.

Who Cannot Join the Study?

Participants must not be pregnant or planning to become pregnant during the study.
Participants should not have any known allergies to the study medications.
Participants must not have a history of blood clots or any condition that increases the risk of blood clots.
Participants should not have severe liver disease.
Participants must not have uncontrolled high blood pressure.
Participants should not have a history of certain types of cancer, such as breast cancer.
Participants must not be currently using other hormonal contraceptives.
Participants should not have a history of severe migraines, especially with aura (visual or sensory disturbances).
Participants must not have any condition that the study doctors believe would make it unsafe to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Uppsala	Uppsala	Sweden
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Estetrol/Drospirenone is a type of combined oral contraceptive pill. It contains two hormones: estetrol, which is a form of estrogen, and drospirenone, which is a form of progestin. These hormones work together to prevent pregnancy by stopping the release of an egg from the ovary, thickening the mucus in the cervix to make it harder for sperm to enter the uterus, and thinning the lining of the uterus to prevent a fertilized egg from attaching. In this clinical trial, researchers are studying how this contraceptive might affect the brain’s structure and function.

Ethinylestradiol/Levonorgestrel is another type of combined oral contraceptive pill. It also contains two hormones: ethinylestradiol, a form of estrogen, and levonorgestrel, a form of progestin. These hormones work in a similar way to prevent pregnancy by stopping ovulation, thickening cervical mucus, and thinning the uterine lining. The trial is examining whether this contraceptive has different effects on the brain compared to the other contraceptive being studied.

Contraception – Contraception refers to methods or devices used to prevent pregnancy. It involves the use of hormonal or barrier methods to inhibit the fertilization of an egg by sperm. Hormonal contraceptives, such as combined oral contraceptives, work by altering hormone levels to prevent ovulation. These methods can also change the cervical mucus to make it difficult for sperm to reach an egg. Over time, the use of hormonal contraceptives can lead to changes in menstrual cycles and may affect mood and weight. The progression of effects varies depending on the type of contraceptive used and individual response.

Trial ID:

2023-507842-10-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Hormonal Contraceptives on the Brain: Comparing Drospirenone and Estetrol with Ethinylestradiol and Levonorgestrel in Women Using Contraception

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?