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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006061-17 | EudraCT Number | EudraCT |
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This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Experimental | multiple doses of Microgynon |
|
| Test | Active Comparator | multiple doses of Microgynon + BI 201335 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel | Drug | multiple doses |
| |
| Ethinylestradiol |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt,ss of Ethinylestradiol | Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration |
| Cmax,ss of Ethinylestradiol | maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
| C24,ss of Ethinylestradiol | measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
| AUCÏ„,ss of Levonorgestrel | Area under the curve over the dosing interval Ï„ under steady state conditions of levonorgestrel | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
| Cmax,ss of Levonorgestrel | maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
| C24,ss of Levonorgestrel |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. | Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | from drug administration up to 14 days |
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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 |
|---|---|---|---|---|---|---|
| 1220.56.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25385099 | Derived | Sabo JP, Lang B, Elgadi M, Huang F. Effect of the hepatitis C virus protease inhibitor faldaprevir on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel in healthy female volunteers. Antimicrob Agents Chemother. 2015 Jan;59(1):514-9. doi: 10.1128/AAC.03589-14. Epub 2014 Nov 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers. Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets. Period 2: Microgynon tablets and Faldaprevir. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Microgynon |
| |||||||||||||
| Microgynon+Faldaprevir |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers. |
| 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 | AUCt,ss of Ethinylestradiol | Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol | Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration |
|
from the time the subject signed the informed consent (56 to 28 days before drug administration) through the observational phase until the end-of-study examination (6 to 14 days after the end of period 2)
During the run-in-period, the volunteers were to be contacted at least twice and asked to report adverse events and concomitant medication. In addition, each volunteer was to be assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
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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 | Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| C552340 | faldaprevir |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Drug |
multiple doses |
|
| levonorgestrel | Drug | multiple doses |
|
| BI 201335 | Drug | multiple doses |
|
| Ethinylestradiol | Drug | multiple doses |
|
measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel
| on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
| Number of Participants With Drug Related Adverse Events | number of participants with investigator-defined drug related adverse events | from drug administration up to 14 days |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Microgynon + Faldaprevir | Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning. Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning. |
|
|
|
| Primary | Cmax,ss of Ethinylestradiol | maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
|
|
|
|
| Primary | C24,ss of Ethinylestradiol | measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
|
|
|
|
| Secondary | Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. | Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment. | Posted | Number | participants | from drug administration up to 14 days |
|
|
|
| Secondary | Number of Participants With Drug Related Adverse Events | number of participants with investigator-defined drug related adverse events | treated set | Posted | Number | participants | from drug administration up to 14 days |
|
|
|
| Primary | AUCÏ„,ss of Levonorgestrel | Area under the curve over the dosing interval Ï„ under steady state conditions of levonorgestrel | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
|
|
|
|
| Primary | Cmax,ss of Levonorgestrel | maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
|
|
|
|
| Primary | C24,ss of Levonorgestrel | measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration |
|
|
|
|
| 0 |
| 16 |
| 12 |
| 16 |
| EG001 | Microgynon + BI 201335 | Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning. Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning. | 0 | 16 | 14 | 16 |
| Ocular icterus | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Asthenia | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Pain | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Swelling | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MEDDRA 15.0 | 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.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |