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CompletedNCT03675581Updated Nov 9, 2020Results posted

A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

A Phase 1 interventional study of Microgynon and Nintedanib in Scleroderma, Systemic, sponsored by Boehringer Ingelheim. Completed at 10 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-09.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Scleroderma, Systemic
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 17 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age >= 18 years
  • A woman of non-child bearing potential, i.e. being postmenopausal1 or permanently sterilised (e.g. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or a woman of childbearing potential correctly and consistently using a highly effective method of non-hormonal birth control (i.e. IUD or bilateral tubal ligation) together with barrier methods at least 30 days prior to first administration of Microgynon® (Visit 2), during the trial and for 3 months after last intake of nintedanib.
  • 2013 American College of Rheumatology (ACR) / European League against Rheumatism (EULAR) classification criteria for Systemic Sclerosis associated Interstitial Lung Disease (SSc) fulfilled
  • SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung >= 10%
  • Forced Vital Capacity (FVC) >= 40% of predicted normal
  • Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
  • Further inclusion criteria apply

Exclusion criteria

Exclusion criteria:

  • Aspartate Transaminase (AST), Alanine Transaminase (ALT) >1.5 x Upper Level of Normal (ULN).
  • Bilirubin >1.5 x ULN
  • Creatinine clearance \<30 mL/min
  • Clinically relevant anaemia at investigators discretion
  • Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \<0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant Pulmonary Hypertension (PH)
  • Cardiovascular diseases
  • More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
  • Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
  • International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
  • History of thrombo-embolic event within last year
  • Previous or planned hematopoietic stem cell transplantation
  • Clinical signs of malabsorption or needing parenteral nutrition
  • Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
  • Previous treatment with nintedanib or pirfenidone
  • Further exclusion criteria apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    All subjects

    Drug: Microgynon · Drug: Nintedanib

Interventions

  • DrugMicrogynon

    fixed sequence trial

  • DrugNintedanib

    fixed sequence trial

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

07

Results

Posted Nov 9, 2020

Participant flow

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).

Period 1: Microgynon Alone
Participant flow — Period 1: Microgynon Alone
MilestoneMicrogynon / Microgynon + Nintedanib
Started17
Completed17
Not completed0
Period 2: Microgynon + Nintedanib
Participant flow — Period 2: Microgynon + Nintedanib
MilestoneMicrogynon / Microgynon + Nintedanib
Started17
Completed17
Not completed0

Outcome measures

PrimaryArea 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.

Time frame:
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.
Reported as:
Geometric mean · picograms * hours per milliliters
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
picograms * hours per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)610.00 ± 1.16618.28 ± 1.16
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 101.36 · 90% CI 92.83 to 110.67The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference
PrimaryArea 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.

Time frame:
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.
Reported as:
Geometric mean · picograms * hours per milliliters
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
picograms * hours per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)33062.73 ± 1.2031872.47 ± 1.20
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 96.40 · 90% CI 91.48 to 101.58The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference
PrimaryMaximum 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.

Time frame:
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.
Reported as:
Geometric mean · picograms per milliliters
Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax)
picograms per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax)54.75 ± 1.1163.89 ± 1.11
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 116.69 · 90% CI 107.63 to 126.51The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference
PrimaryMaximum 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.

Time frame:
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.
Reported as:
Geometric mean · picograms per milliliters
Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax)
picograms per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax)3124.48 ± 1.143152.35 ± 1.14
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 100.89 · 90% CI 89.90 to 113.23The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference
SecondaryArea 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.

Time frame:
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.
Reported as:
Geometric mean · picograms * hours per milliliters
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
picograms * hours per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)749.65 ± 1.14758.95 ± 1.14
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 101.24 · 90% CI 93.95 to 109.10The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference
SecondaryArea 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.

Time frame:
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.
Reported as:
Geometric mean · picograms * hours per milliliters
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
picograms * hours per millilitersMicrogynon Alone (Reference Treatment, R)Microgynon + Nintedanib (Test Treatment, T)
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)56311.68 ± 1.2449605.41 ± 1.24
Statistical analysis
  • Microgynon Alone (Reference Treatment, R) vs Microgynon + Nintedanib (Test Treatment, T) · ANOVA · Ratio of the geometric means (t/r) %: 88.09 · 90% CI 80.03 to 96.96The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Microgynon Alone (Reference Treatment, R)0/17 (0%)0/17 (0%)3/17 (17.6%)
Nintedanib Alone (Before Combination Treatment)0/17 (0%)0/17 (0%)11/17 (64.7%)
Microgynon + Nintedanib (Test Treatment, T)0/17 (0%)1/17 (5.9%)3/17 (17.6%)
Nintedanib Alone (After Combination Treatment)0/17 (0%)0/17 (0%)2/17 (11.8%)
Most frequent serious events
Most frequent serious events
EventMicrogynon Alone (Reference Treatment, R)Nintedanib Alone (Before Combination Treatment)Microgynon + Nintedanib (Test Treatment, T)Nintedanib Alone (After Combination Treatment)
Drug-induced liver injuryHepatobiliary disorders0/170/171/170/17
Most frequent other events
Showing 10 of 16
Most frequent other events
EventMicrogynon Alone (Reference Treatment, R)Nintedanib Alone (Before Combination Treatment)Microgynon + Nintedanib (Test Treatment, T)Nintedanib Alone (After Combination Treatment)
NauseaGastrointestinal disorders0/176/170/170/17
VomitingGastrointestinal disorders0/175/171/170/17
DiarrhoeaGastrointestinal disorders0/174/171/170/17
Abdominal pain upperGastrointestinal disorders0/172/171/170/17
HeadacheNervous system disorders2/171/171/170/17
Abdominal painGastrointestinal disorders0/171/170/170/17
BronchitisInfections and infestations0/171/170/170/17
Respiratory tract infectionInfections and infestations0/171/170/170/17
RhinitisInfections and infestations0/171/170/170/17
DizzinessNervous system disorders1/171/170/170/17

Baseline characteristics

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.

Age, Continuous
Age, Continuous(Years)Microgynon / Microgynon + Nintedanib
Mean59.1 ± 13.2
Sex: Female, Male
Sex: Female, Male(Participants)Microgynon / Microgynon + Nintedanib
Female17
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Microgynon / Microgynon + Nintedanib
Hispanic or Latino2
Not Hispanic or Latino15
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Microgynon / Microgynon + Nintedanib
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander1
Black or African American0
White15
More than one race0
Unknown or Not Reported0
08

Study locations

10 sites
  • UNIV UZ Gent
    Gent, 9000, Belgium
  • HOP Avicenne
    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
09

References and documents

Publications

  • 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. PubMed 34664183 ↗

Related links

Study documents

  • Study protocol · May 2, 2019
  • Statistical analysis plan · Nov 8, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — 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: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03675581
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 18, 2018
Start date
Nov 8, 2018
Primary completion
Oct 9, 2019
Completion
Oct 10, 2019
Results posted
Nov 9, 2020
Last update
Nov 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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