5 results
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
The primary objective of this study will be overall response to treatment with Estetrol in patients with primary Sjogren*s syndrome.
Primary objectives:* To investigate the safety of multiple dosages of E4;* To investigate the efficacy of multiple dosages of E4 on hormone levels related to prostate function.Secondary objectives:* To investigate the pharmacodynamic effects of E4…
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
The purpose of this study is to evaluate the effect of E4 on the efficacy and health related quality of life of prostate cancer patients on LHRH agonist treatment.Primary objectives:• To assess the additional suppressive effects of E4 on total T and…