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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03675581
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : April 16, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Scleroderma, Systemic Drug: Microgynon Drug: Nintedanib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial 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)
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : May 9, 2019
Estimated Study Completion Date : May 10, 2019

Arm Intervention/treatment
Experimental: All subjects Drug: Microgynon
fixed sequence trial

Drug: Nintedanib
fixed sequence trial

Primary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve of the analyte (ethinylestradiol) in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 48 hours ]
  2. AUC0-tz (area under the concentration-time curve of the analyte (levonorgestrel) in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 48 hours ]
  3. Cmax (maximum measured concentration of the analyte (ethinylestradiol) in plasma) [ Time Frame: Up to 48 hours ]
  4. Cmax (maximum measured concentration of the analyte (levonorgestrel) in plasma) [ Time Frame: Up to 48 hours ]

Secondary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte (ethinylestradiol) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 48 hours ]
  2. AUC0-∞ (area under the concentration-time curve of the analyte (levonorgestrel) in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 disease onset (defined by first non-Raynaud symptom) within 7 years
  • 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03675581

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Contact: Boehringer Ingelheim 1-800-243-0127

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UNIV UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Vanessa Smith    +32 (0)9 332 28 56   
HOP Avicenne Recruiting
Bobigny, France, 93009
Contact: Hilario Nunes    +33 (0)1 48 95 51 21   
HOP Bichat Recruiting
Paris, France, 75018
Contact: Bruno Crestani    +33 (0)1 40 25 71 58   
HOP Cochin Recruiting
Paris, France, 75679
Contact: Yannick Allanore    +33 (0)1 58 41 25 72   
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Jörg Distler    +49 (9131) 8535367   
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Antje Prasse    +49 (511) 5323934   
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter    +49 (6221) 3961201   
Radboud Universitair Medisch Centrum Recruiting
Nijmegen, Netherlands, 6525 GL
Contact: Madelon Vonk    +31(0)24-3611111   
Hospital Garcia de Orta, EPE Recruiting
Almada, Portugal, 2801-951
Contact: Ana Cordeiro    +351 212 727 375   
Hospital Fernando Fonseca, EPE Recruiting
Amadora, Portugal, 2720-276
Contact: José Alves    00351 21 4345510   
ULSAM, EPE - Hospital Conde de Bertiandos Recruiting
Ponte de Lima, Portugal, 4990-041
Contact: Jose Costa    +351 258 909 500   
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08026
Contact: Iván Castellví Barranco    +34935565609   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Alfredo Guillén    +34932746003   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT03675581     History of Changes
Other Study ID Numbers: 1199-0340
2018-001177-24 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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:// 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'.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases, Interstitial
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Ethinyl estradiol, levonorgestrel drug combination
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs