At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 17 enrolled
Drug / intervention
Microgynon +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Microgynon and Nintedanib for Scleroderma, Systemic. Completed, enrolled 17 participants across 10 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic
CountriesBelgium, France, Germany, Netherlands, Portugal, Spain
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartNov 2018
Primary CompletionOct 2019
Study CompletionOct 2019
TodayJul 2026
First PostedSep 18, 2018
Enrollment StartNov 8, 2018
Primary CompletionOct 9, 2019
Study CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.8 years ago
Interventions
Microgynondrug
fixed sequence trial
Nintedanibdrug
fixed sequence trial