3 results
Approved WMOCompleted
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
Approved WMOCompleted
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Approved WMOCompleted
The aim of this postmarket study is to compare the safety and effectiveness of Coloplast Restorelle® transvaginal mesh products in the treatment of pelvic organ prolapse (POP) to traditional native tissue repair through 36 months of follow-up. This…