6 results
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
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.
Evaluate the (cost-) effectiveness of ulipristal in comparison with standard surgical treatment for symptomatic uterine fibroids, measured by the symptom severity score of the Uterine Fibroid Symptoms questionnaire (UFS-QOL), a validated Quality of…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)