A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2023-10-04

Brief Summary

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The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Fixed sequence: Run in period-Reference-Treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microgynon®(Run-in)/Microgynon® (treatment reference, R)/ Microgynon®+BI 425809 (treatment test, T)

Group Type EXPERIMENTAL

Microgynon®

Intervention Type DRUG

ethinylestradiol (EE) and levonorgestrel (LNG)

BI 425809

Intervention Type DRUG

BI 425809

Interventions

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Microgynon®

ethinylestradiol (EE) and levonorgestrel (LNG)

Intervention Type DRUG

BI 425809

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes