A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Condition: Scleroderma, Systemic
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse
Intervention: Microgynon; Nintedanib
Intervention description: fixed sequence trial; fixed sequence trial
Intervention MeSH terms: Nintedanib; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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:

          -  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