To navigate the following site navigation expect to utilize the tab key to move through items sequentially. The spacebar or enter keys can be utilized to interact with items that open sub-navigation.
When autocomplete results are available use up and down arrows to review and enter to select.
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
Female
More Inclusion & Exclusion 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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 1
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Boehringer Ingelheim
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Belgium, France, Germany, Netherlands, Portugal, Spain
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Scleroderma, Systemic
Arms & Interventions
Arms
Experimental: All subjects
Interventions
Drug: - Microgynon
fixed sequence trial
Drug: - Nintedanib
fixed sequence trial
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.