Effect of iclepertin on the blood levels of ethinylestradiol and levonorgestrel in healthy premenopausal women

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What is this study about?

A group of healthy premenopausal women, meaning women who have not yet reached menopause, will take part in a study that looks at a medication called BI 425809 and a common birth‑control pill known as Microgynon. Microgynon contains two active ingredients, ethinyl estradiol and levonorgestrel, which work together to prevent pregnancy.

The purpose of the study is to find out whether taking BI 425809 changes the way the body handles the contraceptive hormones, a process known as pharmacokinetics, which includes how the drugs are absorbed, distributed, and cleared from the bloodstream.

Participants will first take the birth‑control pill each day for a set time, then they will start taking the study medication alongside the pill. Blood samples will be collected at several points to see how much of the contraceptive hormones are present in the blood while both medicines are being used. The study will end after the planned treatment period is completed.

1 begin microgynon

on the first day after joining the study, take one microgynon tablet by mouth each day. each tablet contains 30 µg ethinylestradiol (a synthetic estrogen) and 150 µg levonorgestrel (a synthetic progestogen). the tablet is taken once daily with water.

2 run‑in period

continue taking the daily microgynon tablet for several weeks. this period allows the hormone levels in the body to reach a stable condition known as steady state, where the amount entering the bloodstream equals the amount leaving it.

3 baseline blood sampling

during the run‑in period, a series of blood samples are collected. these samples measure the concentration of ethinylestradiol and levonorgestrel before any additional study medication is introduced.

the measurements help determine the normal pharmacokinetic profile, which describes how the body absorbs, distributes, metabolises, and eliminates the hormones.

4 start bi 425809

after baseline sampling, begin taking the oral study drug bi 425809. the dosage is taken as multiple oral doses (exact amount not specified in the source).

continue taking the daily microgynon tablet at the same time each day while the bi 425809 doses are administered.

5 combined medication phase

for the remainder of the study, maintain the daily intake of both microgynon and bi 425809. blood samples are taken at regular intervals to assess any changes in the hormone concentrations.

the primary measurements are the area under the concentration‑time curve (AUCτ,ss), the maximum concentration (Cmax,ss), and the minimum concentration (Cmin,ss) at steady state. these values indicate how the presence of bi 425809 may affect the amount of hormone in the blood.

6 final assessment and study end

at the end of the planned study period (approximately six months, from november 2022 to may 2023), the final set of blood samples is collected.

all study medications are stopped after the last sample. the collected data are then analysed to determine whether bi 425809 influences the pharmacokinetics of the combined oral contraceptive.

Who Can Join the Study?

Be a healthy premenopausal woman, as confirmed by the doctor after reviewing your medical history, a physical exam, checking vital signs such as blood pressure and pulse rate, a 12‑lead ECG (a test that records the heart’s electrical activity), and laboratory tests.
Be between 18 and 35 years old, inclusive.
Have a Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (a calculation that compares weight to height).
Provide a signed and dated written informed consent in line with ICH‑GCP (international standards for good clinical practice) and local laws before entering the trial.
Use effective birth control or meet one of the following from 30 days before the first dose until 30 days after the study ends:
- Use a reliable method such as a non‑hormonal intrauterine device (IUD) plus a condom.
- Remain sexually abstinent.
- Have a partner who had a vasectomy (surgical sterilization) at least one year ago.
- Be surgically sterilized yourself (including a hysterectomy, removal of the uterus).

Who Cannot Join the Study?

Any abnormal finding during the medical examination (including blood pressure, pulse rate, or ECG) that the doctor thinks is important. (Blood pressure is the force of blood in your vessels; pulse rate is how many times your heart beats each minute; ECG is a test that records the heart’s electrical activity.)
Repeated blood pressure or pulse measurements that are outside the normal range: systolic (top number) 90‑140 mmHg, diastolic (bottom number) 50‑90 mmHg, or pulse 45‑90 beats per minute.
Any laboratory test result (such as blood or urine tests) that is outside the normal range and that the doctor believes is important.
Any other existing illness (concomitant disease) that the doctor considers relevant for the study.
Having gastrointestinal (stomach or intestine), liver, kidney, lung, heart, metabolic, immune system, or hormonal disorders.
Having had a gallbladder removal (cholecystectomy) or other stomach/intestine surgery that could affect how the study drug is processed, except simple surgeries like appendix removal or hernia repair.
Having central nervous system disorders such as seizures or stroke, or other serious brain, nerve, or mental health conditions.
History of orthostatic hypotension (a drop in blood pressure when standing), fainting spells, or blackouts.
Having a chronic (long‑lasting) or acute (sudden) infection that is considered relevant.
Any current or suspected cancer (malignancy) or a history of cancer within the past five years, except for a properly treated basal cell carcinoma of the skin (a common, usually low‑risk skin cancer).
Known allergy or severe sensitivity (hypersensitivity) to the study medication or any of its ingredients.
Use of any medication within the last 30 days that could affect the study results, especially drugs that can lengthen the QT/QTc interval (a measurement of the heart’s electrical timing).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Cwr Cvfkhuri Rmvmtcva Suwzacxh Mmhyrbdp Gajz	Mannheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	22.11.2022

Trial locations

Investigated drugs:

BI 425809 is an experimental oral medicine being tested in this study. Researchers are giving it to healthy women to see whether it changes how the body processes the hormones found in a combined birth‑control pill. The drug itself is not approved for regular use and is only being examined for its possible effects in a controlled research setting.

Microgynon is a brand‑name combined oral contraceptive that contains two hormones: ethinylestradiol (an estrogen) and levonorgestrel (a progestin). In this trial, participants take Microgynon regularly to achieve steady levels of these hormones in their blood. The study looks at whether the experimental drug BI 425809 interferes with the normal absorption and clearance of these hormones.

LEVONORGESTREL is a synthetic form of the natural hormone progesterone. It is used alone in some birth‑control methods and is one of the two active ingredients in Microgynon. In the study, levonorgestrel is examined both as part of the combined pill and separately to help understand its individual behavior in the body when the investigational drug is also taken.

ETHINYLESTRADIOL is a synthetic estrogen that is the other active ingredient in the Microgynon pill. It works together with levonorgestrel to prevent pregnancy. The trial monitors how the presence of BI 425809 may affect the way ethinylestradiol is absorbed, distributed, and eliminated from the body.

ICLEPERTIN is an oral medication being studied in the same trial. It belongs to a class of drugs that target specific proteins in the brain and is being evaluated for its safety and how it behaves in the body. While its main purpose in the study is not related to birth control, it is included to see if it interacts with the hormonal contraceptive or the investigational drug.

Healthy – This state refers to a condition where the body functions normally without any detectable disease or impairment. It is characterized by the regular operation of all physiological systems. In this state, there are no signs of illness or abnormal medical processes occurring.

Trial ID:

2022-500050-42-00

Protocol code:

1346-0036

Trial Phase:

Human Pharmacology (Phase I) – Other

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Effect of iclepertin on the blood levels of ethinylestradiol and levonorgestrel in healthy premenopausal women

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?