8 results
To measure APC resistance and SHBG levels as indicators of the risk of venous thrombosis during use of the new developed combined oral contraceptive containing dienogest/estradiolvalerate (Qlaira®) compared with a combined oral contraceptive…
To compare the effects on the APC- (Activated Protein C) resistance ratio (ETP-[endogenous throbin potential] based) between the pivotal phase III NOMAC-E2 batch and a commercial NOMAC-E2 batchTo compare the effects on all other metabolic parameters…
The purpose of this study is: • To examine how the combined oral contraceptive pill, which consists of 30 micrograms ethinyl-estradiol and 150 micrograms levonorgestrel (for instance Microgynon 30®), will be absorbed, metabolized and excreted by the…
Primary objective:To compare the effects of quick starting a combined oral contraceptive on follicular growth and hormonal parameters after ellaOne® or placebo intake.Secondary objective:To compare the effects of quick starting a combined oral…
The primary objective is to compare the efficacy of palifermin relative to placebo when given either pre-and post-high dose chemotherapy or pre-high dose chemotherapy only with regard to the severity of oral mucositis.
To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…
Phase 2 (MF Expansion-Prior JAKi Arm 1 and Add-on to JAKi Arm 2) Primary Objectives:- To evaluate splenic response rate by imaging after 24 weeks of treatment in Cohorts 1B and 2B (i.e., in non-TD cohorts)- To evaluate the rate of conversion from…
Primary• To determine the efficacy of pelabresib + ruxolitinib compared with placebo + ruxolitinibKey Secondary• To determine the effect of pelabresib + ruxolitinib on the absolute change in TSS at Week 24 vs Baseline compared with placebo +…