9 results
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
The primary objective of this study is to investigate local and systemic effects of BAY 1007626 on:- Number of bleeding and spotting days,- Endometrial histology,- Ovulation (as surrogate for systemic effects).The secondary objective of this study…
To assess the PD, PK and safety of the Zoreline 10.8 mg goserelin subcutaneous (SC) implant.
To assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 µg, 400 µg, and 600 µg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
This trial assesses the safety profile of GRT6005 in terms of its effect on respiratory function. Data on its effect on ventilation in a model of respiratory depression will be obtained and compared to fentanyl (a strong opioid with comparable…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
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)
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…