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Study on the Effects of Ethinylestradiol, Levonorgestrel, and Chlormadinone Acetate in Hormonal Contraception for Women Using Oral Contraceptives

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of hormonal contraception on the brain and behavior. The study involves two types of combined oral contraceptives: Selina Gynial, which contains ethinylestradiol and levonorgestrel, and Bilinda Gynial, which contains ethinylestradiol and chlormadinone acetate. These medications are commonly used for birth control and are taken in the form of film-coated tablets.

The purpose of the study is to understand how these oral contraceptives affect brain structure, brain function, and behavior over a period of up to six months. The study will also look at how these effects might change when the medication is stopped. Researchers will examine various factors, such as age and the type of contraceptive used, to see how they might influence the body's response to the medication.

Participants in the study will take the oral contraceptives and undergo assessments to measure changes in mood, self-perception, and cognitive abilities like memory and face recognition. The study will also monitor changes in brain structure and function. Additionally, the study will measure levels of sex hormones, stress hormones, and the contraceptive drugs in the body. Genetic factors that might affect how the body responds to these hormones will also be explored. The study aims to provide a better understanding of the broader effects of hormonal contraception on the body and mind.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, gender, interest in using combined oral contraceptives (COCs), and regularity of menstrual cycles. Proficiency in the German language is also assessed to ensure understanding of instructions.
Step 2
Medication administration
Participants are assigned to take one of the two types of combined oral contraceptives: Selina Gynial or BILINDA GYNIAL. Both are film-coated tablets taken orally.
Selina Gynial contains 0.03 mg of ethinylestradiol and 0.15 mg of levonorgestrel. BILINDA GYNIAL contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
The tablets are taken once daily for a period of up to 6 months.
Step 3
Regular monitoring
Throughout the study, regular monitoring is conducted to assess mood, self-perception, and cognitive functions such as face recognition, verbal fluency, navigation, and working memory.
Brain structure and function are also evaluated to understand the effects of the medication.
Step 4
Hormone level assessment
Blood tests are performed to measure levels of sex hormones such as estradiol, progesterone, and testosterone, as well as stress hormones like cortisol.
The levels of the medications in the body are also monitored.
Step 5
Genetic analysis
Genetic testing is conducted to identify variations in genes related to hormone receptors and neurotransmitter systems. This helps in understanding individual responses to the medication.
Step 6
Final evaluation
At the end of the 6-month period, a final evaluation is conducted to assess the reversibility of any changes observed during the study.
Participants may be asked to stop taking the medication to observe any changes in brain and behavior after withdrawal.

Who can join the trial?

5 criteria

Age between 14 and 35 years.
Must be female.
Have a general interest in taking combined oral contraceptives (COCs) or currently using COCs that contain EE/LNG or EE/CMA. These are types of birth control pills.
Have a regular menstrual cycle for at least 6 months. This means having a cycle that lasts between 21 to 35 days, with no more than a 7-day difference between the lengths of each cycle.
Have enough German language skills to understand and follow task instructions.

Who cannot join the trial?

2 criteria

Participants cannot be male. This study is only for female participants.
Participants must not be part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves.

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Verified sites

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Medizinische Universitaet Innsbruck
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Innsbruck, Austria
Uniklinikum Salzburg
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Salzburg, Austria

Trial locations

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Investigated drugs

EE/LNG
is a combination of two hormones used in oral contraceptives. The first hormone, ethinyl estradiol (EE), is a synthetic form of estrogen, which is a natural hormone in the body. The second hormone, levonorgestrel (LNG), is a synthetic form of progesterone, another natural hormone. Together, these hormones work to prevent pregnancy by stopping the release of eggs from the ovaries and making it harder for sperm to reach any eggs that might be released. In this study, researchers are looking at how this combination affects the brain and behavior over time.
EE/CMA
is another combination of hormones used in oral contraceptives. Like EE/LNG, it contains ethinyl estradiol (EE), a synthetic form of estrogen. The second hormone in this combination is chlormadinone acetate (CMA), which is a synthetic form of progesterone. This combination also works to prevent pregnancy by stopping the release of eggs and making it difficult for sperm to reach any eggs. The study aims to understand how this combination impacts brain structure, function, and behavior over a period of time.

What is already known about the treatment

EE/LNG
This medication is a combined oral contraceptive taken by mouth, commonly used for hormonal birth control. It is well-established in medical literature as an effective method for preventing pregnancy. The main therapeutic indication is hormonal contraception. At the molecular level, it works by preventing ovulation, altering the cervical mucus to hinder sperm movement, and changing the uterine lining to prevent implantation. It belongs to the pharmacological class of combined oral contraceptives, which include both estrogen and progestin components.
EE/CMA
This medication is another form of combined oral contraceptive, also administered orally, and is used for hormonal birth control. It is recognized in medical literature for its role in preventing pregnancy. The primary therapeutic use is hormonal contraception. Its mechanism of action involves stopping ovulation, thickening cervical mucus to block sperm, and modifying the uterine lining to prevent a fertilized egg from implanting. It is classified pharmacologically as a combined oral contraceptive, containing both estrogen and progestin.

Investigated diseases

Hormonal contraception – Hormonal contraception refers to the use of hormones to prevent pregnancy. It typically involves the administration of synthetic hormones, such as estrogen and progestin, which work by inhibiting ovulation, altering the uterine lining, and thickening cervical mucus to prevent sperm from reaching an egg. Over time, the body adjusts to these hormonal changes, which can affect menstrual cycles and may lead to changes in mood, weight, and other bodily functions. The effects of hormonal contraception can vary depending on the type and dosage of hormones used. Upon discontinuation, the body gradually returns to its natural hormonal cycle, and fertility is typically restored. Hormonal contraception is widely used and studied for its effects on various aspects of health beyond pregnancy prevention.