5 results
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
The objective of this study is to confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangiopancreatography (ERCP) or other duodenoscope-based procedures.
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…