Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
Status:
Completed
Trial end date:
2018-10-04
Target enrollment:
Participant gender:
Summary
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency
in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA
and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK)
characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target
population.
Phase:
Phase 1
Details
Lead Sponsor:
Diurnal Limited
Collaborators:
Brush Clinical Research Limited Brush Clinical Research Ltd. Covance EMAS Pharma Emas Pharma Limited Envigo Pharma Consulting Limited Manchester University NHS Foundation Trust Medical Matters International Medical Matters International Ltd. Sheffield Teaching Hospitals NHS Foundation Trust Simbec Research University Hospital of South Manchester NHS Foundation Trust Voet Consulting