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A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

- 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…

Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study)

This study has been transitioned to CTIS with ID 2024-516414-38-00 check the CTIS register for the current data. Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and…

A phase III, open label, randomized study to assess the efficacy and safety of Olaparib (Lynparza*)versus Enzalutamide or Abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations

To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…