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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Scleroderma, Systemic

Treatments

Drug: Nintedanib

Drug: Microgynon

Study type

Interventional

Funder types

Industry

Identifiers

NCT03675581

1199-0340

2018-001177-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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