5 results
Primary ObjectivesIn patients with primary hypercholesterolemia and high cardiovascular risk with LDL-C >=100 mg/dL (2.59 mmol/L) and <=160 mg/dL (4.14 mmol/L), to evaluate:1)at the end of Phase I, the additional LDL-C percentage…
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…
- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…
The aim of the current study is to extend the time to develop new disease progression in prostate cancer patients with recurrent disease in the form of limited metastases (<5) and in some cases possibly even cure by adding 6 months of ADT to…
All efficacy and safety objectives will compare enzalutamide plus leuprolide and enzalutamide monotherapyversus placebo plus leuprolide.