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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001177-24 | EudraCT Number |
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The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgynon | Drug | fixed sequence trial |
| |
| Nintedanib |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax) | Maximum measured concentration of ethinylestradiol in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIV UZ Gent | Ghent | 9000 | Belgium | |||
| HOP Avicenne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34664183 | Derived | Vonk MC, Guillen-Del-Castillo A, Kreuter M, Avis M, Marzin K, Mack SR, Wind S, Gahlemann M. A Drug-Drug Interaction Study to Investigate the Effect of Nintedanib on the Pharmacokinetics of Microgynon (Ethinylestradiol and Levonorgestrel) in Female Patients with Systemic Sclerosis-Associated Interstitial Lung Disease. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):81-89. doi: 10.1007/s13318-021-00728-7. Epub 2021 Oct 18. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the patients) strictly met all inclusion and none of the exclusion criteria. Patients were not to be allocated to a treatment group if any of the entry criteria were violated.
This is an open-label, 2-period, fixed-sequence, Phase I trial in order to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in female patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
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| ID | Title | Description |
|---|---|---|
| FG000 | Microgynon / Microgynon + Nintedanib | Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R). Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). All treatments were to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Microgynon Alone |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2019 | Oct 5, 2020 |
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| Drug |
fixed sequence trial |
|
| 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax) | Maximum measured concentration of levonorgestrel in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| Bobigny |
| 93009 |
| France |
| HOP Bichat | Paris | 75018 | France |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Radboud Universitair Medisch Centrum | Nijmegen | 6525 GL | Netherlands |
| Hospital Garcia de Orta, EPE | Almada | 2801-951 | Portugal |
| Hospital Fernando Fonseca, EPE | Amadora | 2720-276 | Portugal |
| Hospital Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2: Microgynon + Nintedanib |
|
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Microgynon / Microgynon + Nintedanib | Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R). Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). All treatments were to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms * hours per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms * hours per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
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| Primary | Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax) | Maximum measured concentration of ethinylestradiol in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax) | Maximum measured concentration of levonorgestrel in plasma (Cmax). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
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| Secondary | Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of ethinylestradiol were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms * hours per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). For Microgynon (ethinylestradiol + levonorgestrel) alone (Reference treatment, R) and Microgynon (ethinylestradiol + levonorgestrel) + nintedanib (Test treatment, T) plasma concentrations of levonorgestrel were measured 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after Microgynon administration alone or in combination with nintedanib. | Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that had been defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Standard Error | picograms * hours per milliliters | 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib. |
|
The adverse events collection time frame started at the day of first administration of the treatment till 2 days after for Microgynon alone, till 10 days after for nintedanib (before combination treatment), till 2 days after for Microgynon + nintedanib and as from 3 days after the combination treatment for nintedanib alone.
Treated set (TS): The TS included all subjects who had been enrolled and treated with at least 1 dose of study drug. The treated set was used for safety analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microgynon Alone (Reference Treatment, R) | Period 1 consisted of a Microgynon alone treatment. All patients received a single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel at trial Day -3 (Reference treatment, R). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. | 0 | 17 | 0 | 17 | 3 | 17 |
| EG001 | Nintedanib Alone (Before Combination Treatment) | All patients received a continuous stable dose of nintedanib, 150 mg twice daily (bid) (300 mg total per day), soft gelatine capsule from trial Day 1 for at least 10 consecutive days. The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed. | 0 | 17 | 0 | 17 | 11 | 17 |
| EG002 | Microgynon + Nintedanib (Test Treatment, T) | Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed. | 0 | 17 | 1 | 17 | 3 | 17 |
| EG003 | Nintedanib Alone (After Combination Treatment) | All patients continued to receive a stable dose of nintedanib, 150 mg bid (300 mg total per day), soft gelatine capsule after the combination treatment on trial Days 12 and 13. The treatment was to be taken with food, swallowed whole with approximately 250 mL of water and was not to be chewed or crushed. AE's are considered to have occurred on nintedanib alone (after combination treatment) if occurring on Day 14 or later, i.e. at least 3 days after combination treatment. | 0 | 17 | 0 | 17 | 2 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 22.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2019 | Oct 5, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Microgynon + Nintedanib (Test Treatment, T) | Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
|
|
|
Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
|
|
|
Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
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| OG001 | Microgynon + Nintedanib (Test Treatment, T) | Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
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| OG001 | Microgynon + Nintedanib (Test Treatment, T) | Period 2 consisted of a Microgynon + nintedanib combination treatment. All patients received a continuous stable dose of nintedanib, soft gelatine capsule of 150 milligrams (mg) twice daily (bid) (300 mg total per day), starting from trial Day 1 over a period of at least 14 days to approximately 28 days. After at least 10 days of nintedanib treatment, all patients received a second single dose of Microgynon: 1 tablet of 30 μg ethinylestradiol and 150 μg levonorgestrel on trial Day 11 (Test treatment, T). The treatment was to be taken with food, swallowed whole with approximately 250 milliliters (mL) of water and was not to be chewed or crushed. |
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