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

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.

Timeline

Start

2018-11-08

Primary completion

2019-10-09

Completion

2019-10-10

Publications

• Vonk MC, Guillen-Del-Castillo A, Kreuter M, Avis M, Marzin K, Mack SR, Wind S, Gahlemann M. A Drug-Drug Interaction Study to Investigate the Effect of Nintedanib on the Pharmacokinetics of Microgynon (Ethinylestradiol and Levonorgestrel) in Female Patients with Systemic Sclerosis-Associated Interstitial Lung Disease. Eur J Drug Metab Pharmacokinet. 2022 Jan;47(1):81-89. doi: 10.1007/s13318-021-00728-7. Epub 2021 Oct 18.

Drugs

Indications