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The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of ethinylestradiol / levonorgestrel (Microgynon®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microgynon® 30 +BI 409306 then BI 409306 alone | Experimental | Run in period: Microgynon alone Treatment period: Microgynon® 30 +BI 409306 then BI 409306 alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgynon® 30 | Drug | Run in period & Treatment Period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29). | PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
| Maximum Measured Concentration of BI 409306 in Plasma (Cmax) | Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29). | PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
| Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss) | AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18). |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | AUC0-infinity, area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of 1 tablet of 25 mg BI 409306 alone (Day 29). |
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Inclusion Criteria:
Healthy CYP2C19 PM genotyped premenopausal female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
Korean ethnicity according to the following criteria
;be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea
Age of 19 to 40 years (incl.)
Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Open-label, two-period, fixed-sequence trial to investigate potential drug-drug interactions between BI 409306 and Microgynon® (ethinylestradiol and levonorgestrel). In run-in period, subjects were adjusted to Microgynon® treatment and in treatment period, BI 409306 and Microgynon® were either administered alone or in combination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Microgynon® 30 + BI 409306 Then BI 409306 Alone | Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21. On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)). On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Microgynon® 30 + BI 409306 |
| |||||||||||||
| Period 2 - BI 409306 Alone |
|
Treated set (TS) : The TS includes all subjects from the Entered set (ES; includes all entered subjects irrespective of treatment) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Microgynon® 30 + BI 409306 Then BI 409306 Alone | Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21. On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)). On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | TS |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | nanomoles*hour/Litre [nmol*h/L] | PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
From first drug administration until 6 days after last drug administration, up to 35 days.
This subject set included all subjects from the entered set (all entered subjects, whether treated or not) who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microgynon® 30 Alone (R2) | Subjects were administered orally 1 tablet of Microgynon® 30 alone on Day 17 (at steady state) (Reference 2 (R2)). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2017 | Jul 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2018 | Jul 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000630656 | BI 409306 |
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| BI 409306 |
| Drug |
Day 18 & 29 (Treatment Period) |
|
| PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
| Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss) | AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18). | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
| Maximum Measured Concentration of Ethinylestradiol in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18). | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
| Maximum Measured Concentration of Levonorgestrel in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18). | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
| PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
| Standard Deviation |
| Years |
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| Sex: Female, Male | TS | Count of Participants | Participants |
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| Race (NIH/OMB) | TS | Count of Participants | Participants |
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|
| Primary | Maximum Measured Concentration of BI 409306 in Plasma (Cmax) | Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | nanomoles/Litre [nmol/L] | PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
|
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| Primary | Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss) | AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | Picograms*hour/millilitre [pg*h/mL] | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
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|
| Primary | Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss) | AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | Picograms*hour/millilitre [pg*h/mL] | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
|
|
|
|
| Primary | Maximum Measured Concentration of Ethinylestradiol in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | Picograms/millilitre [pg/mL] | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
|
|
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| Primary | Maximum Measured Concentration of Levonorgestrel in Plasma at Steady State (Cmax,ss) | Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | Picograms/millilitre [pg/mL] | PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18). |
|
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| Secondary | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | AUC0-infinity, area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of 1 tablet of 25 mg BI 409306 alone (Day 29). | Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP). | Posted | Geometric Least Squares Mean | Standard Error | Nanomole*hour/milllilitre [nmol*h/mL] | PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29). |
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|
| 0 |
| 16 |
| 0 |
| 16 |
| 9 |
| 16 |
| EG001 | BI 409306 + Microgynon® 30 (T1) | Subjects were administered orally 1 tablet of 25 milligram (mg) BI 409306 together with 1 tablet Microgynon® 30 on Day 18 (Test 1 (T1)). | 0 | 16 | 0 | 16 | 11 | 16 |
| EG002 | BI 409306 Alone (R1) | Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 (Reference 1 (R1)). | 0 | 16 | 0 | 16 | 12 | 16 |
| EG003 | Total BI409306 | Subjects were administered orally 1 tablet of 25 mg BI 409306 alone on Day 29 or 1 tablet of 25 mg BI 409306 together with 1 tablet Microgynon® 30 on Day 18. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG004 | Microgynon® 30 + BI 409306 Then BI 409306 Alone | Participants were administered once daily orally one coated tablet (sugar coated) of Microgynon® 30 (containing 30 microgram (μg) ethinylestradiol (EE) and 150 μg levonorgestrel (LNG)) from Day 1 to Day 21. On Day 18 additionally to Microgynon®30, participants were also administered once daily orally one film coated tablet of 25 milligram (mg) of BI 409306 (Test 1 (T1)). On Day 29 participants were administered once daily orally one film coated tablet of 25 mg of BI 409306 (Reference 1 (R1)). | 0 | 16 | 0 | 16 | 15 | 16 |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Visual brightness | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abnormal sensation in eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Vessel puncture site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Tooth injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.