Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500050-42-00 | Registry Identifier | CTIS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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®).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microgynon® (R), then Microgynon® + Iclepertin (T) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgynon® | Drug | ethinylestradiol (EE) and levonorgestrel (LNG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
| Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
| Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. |
Not provided
Not provided
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:
Exclusion Criteria:
Subjects will not be allowed to participate, if any of the following general criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40906309 | Derived | Madari S, Balavarca Y, Shatillo Y, Reuteman-Fowler C, Desch M. The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females. Clin Drug Investig. 2025 Oct;45(10):767-779. doi: 10.1007/s40261-025-01472-5. Epub 2025 Sep 4. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
All participants were screened for eligibility prior to participation in the trial. Participants were not to be allocated to a treatment group if any of the entry criteria were violated. Nineteen participants enrolled in the trial but only 17 were treated according to the clinical trial protocol: one participant was not treated due to an adverse event (AE) prior to the run-in period, and one other participant was treated with OC but did not start Period 1 and 2 due to an AE.
This was a non-randomised, open-label, 2-period, fixed sequence trial with a run-in period and without a wash-out period between the treatments to test whether Iclepertin (BI 425809) influences the amount of a contraceptive (Microgynon®) in the blood. Participants underwent a run-in period of at least 28 days before the Period 1 of the trial to exclude any possible interactions with preceding oral contraceptive regime (OC) and to minimize the influence of adaptation to a newly administered OC.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Microgynon® (R), Then Microgynon® + Iclepertin (T) | Participants received two treatments in the following order: Period 1 - Microgynon® (R): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory. Period 2 - Microgynon® + Iclepertin (T): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours. There was no wash-out period between Period 1 and Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Microgynon® (R) |
| |||||||||||||
| Period 2 - Microgynon® + Iclepertin (T) |
|
Treated set (TS): All subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Microgynon® (R), Then Microgynon® + Iclepertin (T) | Participants received two treatments in the following order: Period 1 - Microgynon® (R): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory. Period 2 - Microgynon® + Iclepertin (T): Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours. There was no wash-out period between Period 1 and Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | This outcome measured the area under the concentration-time curve of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour*picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
Adverse event (AE) reporting and all-cause mortality: Microgynon® (Run-in) - From initial Microgynon® intake until the 1st intake of Microgynon® in R period or end of study visit. Up to 57 days. AE reporting and all-cause mortality: Microgynon® (R) - From initial Microgynon® intake until the 1st intake of Microgynon® + Iclepertin. Up to 28 days. AE reporting: Microgynon® + Iclepertin (T): Up to 32 days. All-cause mortality: Up to 42 days. Details in the description.
Entered set: all subjects who were entered to the study.
Time frame (continued):
Microgynon® + Iclepertin (T) - From first intake of Microgynon® + Iclepertin until its last intake plus 11 days. Up to 32 days. All-cause mortality was recorded from first intake of Microgynon® + Iclepertin until the end of study visit day. Up to 42 days.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microgynon® (Run-in) | Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings for 21-49 days (depending on duration of menstrual cycle), followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2022 | Mar 2, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2023 | Mar 2, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C000634404 | BI 425809 |
Not provided
Not provided
Not provided
Fixed sequence: Run in period-Reference-Treatment
Not provided
Not provided
Not provided
Not provided
| Iclepertin | Drug | Iclepertin |
|
|
| From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
| Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
| Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss ) | This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
| Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss ) | This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Microgynon® (R) | Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory. |
| OG001 | Microgynon® + Iclepertin (T) | Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours. |
|
|
|
| Primary | Area Under the Concentration-time Curve of Levonogestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | This outcome measured the area under the concentration-time curve of levonogestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | hour*picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
|
|
|
| Primary | Maximum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | This outcome measured the maximum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
|
|
|
| Primary | Maximum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | This outcome measured the maximum measured concentration of levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
|
|
|
| Primary | Minimum Measured Concentration of Ethinylestradiol (EE) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss ) | This outcome measured the minimum measured concentration of ethinylestradiol (EE), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
|
|
|
| Primary | Minimum Measured Concentration of Levonorgestrel (LNG) in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss ) | This outcome measured the minimum measured concentration of Levonorgestrel (LNG), an active ingredient of Microgynon®, in plasma at steady state over a uniform dosing interval, following the administration of Microgynon® with and without Iclepertin. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model including effects on the sources of variation: treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed. | Pharmacokinetic (PK) parameter analysis set: all subjects who were treated with at least one dose of trial drug during the trial treatment periods (Period 1 and Period 2) and who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | picogram/milliliter | From within 10 minutes before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after the administration of Microgynon® with and without Iclepertin on day 21. |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 12 |
| 18 |
| EG001 | Microgynon® (R) | Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) in the mornings of days 1 to 21, followed by 7 days where the treatment was not administered. Microgynon® was administered orally with 240 millilitres of water after an overnight fast of at least 10 hours on day 1, and day 18 to 21. On days 2 to 17 fasting was not mandatory. | 0 | 17 | 0 | 17 | 13 | 17 |
| EG002 | Microgynon® + Iclepertin (T) | Participants received once daily one sugar-coated tablet of Microgynon® (30 micrograms (μg) ethinylestradiol and 150 μg levonorgestrel) and one 10 milligram film-coated tablet of Iclepertin (BI 425809) in the mornings of day 1 to 21, followed by 7 days where no treatment was administered. Iclepertin and Microgynon® were administered orally with 240 millilitres of water after an overnight fast of at least 10 hours. | 0 | 17 | 0 | 17 | 15 | 17 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
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.