Will this new pill mess with your birth control? study finds out
NCT ID NCT05613777
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checked whether taking iclepertin (a drug being tested for other conditions) changes how the body handles a common birth control pill. Nineteen healthy women took the birth control pill with and without iclepertin, and researchers measured hormone levels in their blood. The goal was to see if iclepertin affects birth control effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iclepertin (BI 425809) and a combination birth control pill (ethinylestradiol and levonorgestrel)
- What this could lead to
- If successful, this study could show that iclepertin does not interfere with birth control, allowing women to use both safely together.
- What could go wrong
- This is a small, early-phase trial in healthy volunteers, not patients. It only looks at drug levels in the blood, not real-world effectiveness or side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
19 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Oct 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 35 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure(BP), Pulse rate (PR)), 12-lead Electrocardiogram (12-lead ECG), and clinical laboratory tests without any clinically significant abnormalities. * Age of 18 to 35 years (inclusive). * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive). * Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. * Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of BI 425809 and until 30 days after trial completion: * Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom. * Sexually abstinent. * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment). * Surgically sterilised (including hysterectomy). Exclusion Criteria: Subjects will not be allowed to participate, if any of the following general criteria apply: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm). * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair). * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders. * History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
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