5 results
Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
Primary• Evaluate the efficacy of 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56 • Evaluate the safety of VE202 in Part 1 and Part 2 of the study Secondary objectiveSecondary objective1. Evaluate the safety of VE202 in…
Primary:• To evaluate the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (<= 50 ng/dL [1.7 nmol/L]) in men with androgen-sensitive advanced prostate cancer.Secondary:• To evaluate the time…
All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.