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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023432-16 | EudraCT Number | EudraCT |
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The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Experimental | multiple doses of Microgynon |
|
| Test | Active Comparator | multiple doses of Microgynon + BI 10773 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel | Drug | multiple doses |
| |
| levonorgestrel |
| Measure | Description | Time Frame |
|---|---|---|
| Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval Ï„. | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval Ï„. | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) | Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval Ï„. | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Maximum Measured Concentration (Cmax,ss) | Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval Ï„. | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
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Inclusion criteria:
1. Healthy female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.41.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23512637 | Derived | Macha S, Mattheus M, Pinnetti S, Woerle HJ, Broedl UC. Effect of empagliflozin on the steady-state pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female volunteers. Clin Drug Investig. 2013 May;33(5):351-7. doi: 10.1007/s40261-013-0068-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Overall | A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days. |
| 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 | Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval Ï„. | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
day1 to day17
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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 | One tablet of Microgynon once daily for 14 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Drug |
multiple doses |
|
| Ethinylestradiol | Drug | multiple doses |
|
| Microgynon + BI 10773 | Drug | multiple doses BI 10773 |
|
| Ethinylestradiol | Drug | multiple doses |
|
| Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) | Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) | Apparent clearance of levonorgestrel in the plasma at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Apparent volume of distribution during the terminal phase at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Apparent volume of distribution during the terminal phase at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) | Terminal half-life of ethinylestradiol in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) | Terminal half-life of levonorgestrel in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) | Terminal rate constant of ethinylestradiol in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) | Terminal rate constant of levonorgestrel in plasma at steady state | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) | Mean residence time of ethinylestradiol in the body at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) | Mean residence time of levonorgestrel in the body at steady state after oral administration | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
| Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. | Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events. | Day 1 to day 17 |
| Assessment of Tolerability | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable. | Within Day 24 to Day 31 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Microgynon Plus Empa |
One tablet of Microgynon once daily plus empa 25mg once daily for seven days |
|
|
|
| Primary | Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval Ï„ (AUCÏ„,ss) | Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval Ï„. | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
|
| Primary | Ethinylestradiol: Maximum Measured Concentration (Cmax,ss) | Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval Ï„. | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
|
| Primary | Levonorgestrel: Maximum Measured Concentration (Cmax,ss) | Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval Ï„. | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
|
| Secondary | Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Median | Full Range | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss) | Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Median | Full Range | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss) | Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Apparent Clearance at Steady State (CL/Fss) | Apparent clearance of levonorgestrel in the plasma at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Apparent volume of distribution during the terminal phase at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss) | Apparent volume of distribution during the terminal phase at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss) | Terminal half-life of ethinylestradiol in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss) | Terminal half-life of levonorgestrel in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss) | Terminal rate constant of ethinylestradiol in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss) | Terminal rate constant of levonorgestrel in plasma at steady state | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss) | Mean residence time of ethinylestradiol in the body at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss) | Mean residence time of levonorgestrel in the body at steady state after oral administration | Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours(h) | Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20. |
|
|
|
| Secondary | Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests. | Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events. | Treated set (TS) included all subjects who took at least one dose of study medication. | Posted | Number | participants | Day 1 to day 17 |
|
|
|
| Secondary | Assessment of Tolerability | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable. | Treated set (TS) included all subjects who took at least one dose of study medication. | Posted | Number | percentage of participants | Within Day 24 to Day 31 |
|
|
|
| 0 |
| 18 |
| 10 |
| 18 |
| EG001 | Microgynon Plus Empa | One tablet of Microgynon once daily plus empa 25mg once daily for seven days | 0 | 18 | 10 | 18 |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Thirst | General disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MEDDRA 14.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|