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Trial record 32 of 404 for:    LEVONORGESTREL

Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Patients With Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02751385
Recruitment Status : Terminated (Terminated- Study halted due to low recruitment.)
First Posted : April 26, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: Microgynon
Drug: Nintedanib
Enrollment 2
Recruitment Details Phase I study to investigate the effect of multiple oral doses of nintedanib on the single dose kinetics of a combination of ethinylestradiol and levonorgestrel (Microgynon®) in patients with non-small cell lung cancer.
Pre-assignment Details All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all subjects met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Arm/Group Title Microgynon® Microgynon® With Nintedanib
Hide Arm/Group Description Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Period Title: Period 1
Started 2 0
Completed 2 0
Not Completed 0 0
Period Title: Period 2
Started 0 2
Completed 0 2
Not Completed 0 0
Arm/Group Title All Patients
Hide Arm/Group Description

Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®. Same subjects were continued to Period 2, hence baseline characteristics are presented by Period 1.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
Treated set (TS)- This patient set includes all patients in the Entered Set (ES) who were documented to have received one dose of study drug.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
67.0  (11.3)
[1]
Measure Analysis Population Description: TS
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
[1]
Measure Analysis Population Description: TS
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: TS
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: TS
1.Primary Outcome
Title Area Under the Concentration-time Curve of the the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Hide Description

Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.

In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.

Time Frame Please refer to description section for the details about the actual sampling time points
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set (PKS): This analysis set includes all patients in the Treated Set (TS) who contributes only one PK parameter value for one period to the statistical assessment.
Arm/Group Title Microgynon® Microgynon® With Nintedanib
Hide Arm/Group Description:
Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Overall Number of Participants Analyzed 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram*hour/mililiter
Ethinylestradiol Number Analyzed 2 participants 1 participants
410
(6.61%)
348 [1] 
(NA%)
Levonorgestrel Number Analyzed 2 participants 1 participants
41500
(11.0%)
43600 [1] 
(NA%)
[1]
Only one patient was analysed, thus Geometric coefficient of variation (gCV) was not calculated.
2.Primary Outcome
Title Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel
Hide Description

Maximum blood concentrations (Cmax) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.

In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.

Time Frame Please refer to description section for the details about the actual sampling time points
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set (PKS): This analysis set includes all patients in the TS who contributes only one PK parameter value for one period to the statistical assessment.
Arm/Group Title Microgynon® Microgynon® With Nintedanib
Hide Arm/Group Description:
Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Overall Number of Participants Analyzed 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram/milliliter[pg/mL]
Ethinylestradiol Number Analyzed 2 participants 1 participants
32.6
(3.04%)
36.9 [1] 
(NA%)
Levonorgestrel Number Analyzed 2 participants 1 participants
2680
(23.2%)
1630 [1] 
(NA%)
[1]
Only one patient was analysed, thus Geometric coefficient of variation (gCV) was not calculated.
3.Secondary Outcome
Title Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).
Hide Description

Area under curve from zero to infinity (AUC0-∞) for ethinylestradiol and for levonorgestrel after intake of a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.

In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®.

Time Frame Please refer to description section for the details about the actual sampling time points
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set (PKS): This analysis set includes all patients in the TS who contributes only one PK parameter value for one period to the statistical assessment.
Arm/Group Title Microgynon® Microgynon® With Nintedanib
Hide Arm/Group Description:
Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1.

Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg, if required) for at least 7 consecutive days in Period 2.

Nintedanib was to be taken continuously throughout Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they had taken nintedanib for at least 7 consecutive days before intake of Microgynon®.

Overall Number of Participants Analyzed 2 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg*h/mL
Ethinylestradiol
503
(0.394%)
580 [1] 
(NA%)
Levonorgestrel
54500
(9.52%)
57600 [1] 
(NA%)
[1]
Only one patient was analysed, thus Geometric coefficient of variation (gCV) was not calculated.
Time Frame From first drug administration until 3 days after the last drug administration. Up to 13 days for Microgynon. From first drug administration until 30 days after the last drug administration. Up to 34 days for nintedanib.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Microgynon® Loading Nintedanib Nintedanib+Microgynon® Nintedanib
Hide Arm/Group Description Patients were orally administered one tablet of Microgynon® (combination of 30 microgram ethinylestradiol and 150 microgram levonorgestrel per tablet) after a standardised breakfast in Period 1. Patients on nintedanib loading phase Patients were orally administered one tablet of Microgynon® after continuous 2x2 nintedanib soft gelatine capsule containing 100 mg per day (with dose reduction to 2x1 capsule containing 150 mg if required) for at least 7 consecutive days in Period 2. Nintedanib was to be taken continuously throughout in Period 2. In case of a temporary interruption of nintedanib intake, patients could receive Microgynon® in Period 2 only if they have taken nintedanib for at least 7 consecutive days before intake of Microgynon®. Patients administered with nintedanib
All-Cause Mortality
Microgynon® Loading Nintedanib Nintedanib+Microgynon® Nintedanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Microgynon® Loading Nintedanib Nintedanib+Microgynon® Nintedanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Microgynon® Loading Nintedanib Nintedanib+Microgynon® Nintedanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)   1/2 (50.00%)   1/2 (50.00%)   0/2 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%) 
Investigations         
Hepatic enzyme increased  1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other - 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02751385     History of Changes
Other Study ID Numbers: 1199.238
2015-005664-41 ( EudraCT Number )
First Submitted: April 22, 2016
First Posted: April 26, 2016
Results First Submitted: November 22, 2018
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019