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) (1199-0340)

Study identification

• EU PAS number:
  EUPAS40026
• Study ID:
  40027
• Official title and acronym:
  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) (1199-0340)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Netherlands

  Portugal

  Spain
• Study description:
  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 status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:06/11/2017

Study start date

Actual:08/11/2018

Data analysis start date

Actual:15/11/2019

Date of final study report

Actual:02/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable