Trials / Completed
CompletedNCT03675581
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Microgynon | fixed sequence trial |
| DRUG | Nintedanib | fixed sequence trial |
Timeline
- Start date
- 2018-11-08
- Primary completion
- 2019-10-09
- Completion
- 2019-10-10
- First posted
- 2018-09-18
- Last updated
- 2020-11-09
- Results posted
- 2020-11-09
Locations
10 sites across 6 countries: Belgium, France, Germany, Netherlands, Portugal, Spain
Source: ClinicalTrials.gov record NCT03675581. Inclusion in this directory is not an endorsement.