Trial Outcomes & Findings for Drug-drug Interaction of BI 201335 and Microgynon (NCT NCT01570244)
NCT ID: NCT01570244
Last Updated: 2015-08-03
Results Overview
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
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
Results posted on
2015-08-03
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Microgynon
STARTED
|
16
|
|
Microgynon
COMPLETED
|
16
|
|
Microgynon
NOT COMPLETED
|
0
|
|
Microgynon+Faldaprevir
STARTED
|
16
|
|
Microgynon+Faldaprevir
COMPLETED
|
15
|
|
Microgynon+Faldaprevir
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Microgynon+Faldaprevir
Adverse Event
|
1
|
Baseline Characteristics
Drug-drug Interaction of BI 201335 and Microgynon
Baseline characteristics by cohort
| Measure |
All Subjects
n=16 Participants
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.
|
|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 5.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 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.
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
AUCt,ss of Ethinylestradiol
|
1010 pg*h/mL
Geometric Coefficient of Variation 23.5
|
1450 pg*h/mL
Geometric Coefficient of Variation 27.8
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK set
maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
Cmax,ss of Ethinylestradiol
|
108 pg/mL
Geometric Coefficient of Variation 23.6
|
127 pg/mL
Geometric Coefficient of Variation 25.1
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK set
measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
C24,ss of Ethinylestradiol
|
19.1 pg/mL
Geometric Coefficient of Variation 32.9
|
33.2 pg/mL
Geometric Coefficient of Variation 42.9
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK set
Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
AUCτ,ss of Levonorgestrel
|
83.3 ng*h/mL
Geometric Coefficient of Variation 42.0
|
120 ng*h/mL
Geometric Coefficient of Variation 40.6
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK set
maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
Cmax,ss of Levonorgestrel
|
7.57 ng/mL
Geometric Coefficient of Variation 34.9
|
8.95 ng/mL
Geometric Coefficient of Variation 33.3
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: PK set
measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=15 Participants
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.
|
|---|---|---|
|
C24,ss of Levonorgestrel
|
2.43 ng/mL
Geometric Coefficient of Variation 49.4
|
3.85 ng/mL
Geometric Coefficient of Variation 47.9
|
SECONDARY outcome
Timeframe: from drug administration up to 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=16 Participants
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.
|
|---|---|---|
|
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: from drug administration up to 14 daysPopulation: treated set
number of participants with investigator-defined drug related adverse events
Outcome measures
| Measure |
Microgynon
n=16 Participants
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + Faldaprevir
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Drug Related Adverse Events
|
2 participants
|
15 participants
|
Adverse Events
Microgynon
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Microgynon + BI 201335
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microgynon
n=16 participants at risk
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
|
Microgynon + BI 201335
n=16 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/16 • 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.
|
37.5%
6/16 • 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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • 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.
|
25.0%
4/16 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • 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.
|
12.5%
2/16 • 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.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
1/16 • 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.
|
0.00%
0/16 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 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.
|
50.0%
8/16 • 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.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • 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.
|
25.0%
4/16 • 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.
|
|
General disorders
Asthenia
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
General disorders
Fatigue
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
General disorders
Pain
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
General disorders
Swelling
|
6.2%
1/16 • 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.
|
0.00%
0/16 • 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.
|
|
Infections and infestations
Oral herpes
|
12.5%
2/16 • 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.
|
0.00%
0/16 • 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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • 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.
|
43.8%
7/16 • 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.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/16 • 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.
|
12.5%
2/16 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • 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.
|
0.00%
0/16 • 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.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • 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.
|
6.2%
1/16 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • 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.
|
18.8%
3/16 • 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.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • 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.
|
37.5%
6/16 • 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.
|
|
Nervous system disorders
Orthostatic intolerance
|
6.2%
1/16 • 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.
|
0.00%
0/16 • 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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/16 • 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.
|
12.5%
2/16 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.2%
1/16 • 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.
|
0.00%
0/16 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • 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.
|
6.2%
1/16 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • 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.
|
6.2%
1/16 • 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.
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • 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.
|
18.8%
3/16 • 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.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER