Phase 1
Completed N=17
A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Scleroderma, Systemic
Source: ClinicalTrials.gov NCT03675581 ↗
Enrolled (actual)
17
Serious AEs
1.5%
Results posted
Nov 2020
Primary outcomePrimary: Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 610.00; 618.28 picograms * hours per milliliters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
610.00; 618.28 | — |
| PRIMARY Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
33062.73; 31872.47 | — |
| PRIMARY Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax) |
54.75; 63.89 | — |
| PRIMARY Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax) |
3124.48; 3152.35 | — |
| SECONDARY Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
749.65; 758.95 | — |
| SECONDARY Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
56311.68; 49605.41 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03675581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.