drugset / Trial / NCT02966652
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
Phase 1
Completed
25 enrolled
Neurocrine UK Limited
Brush Clinical Research Ltd. · collabCovance · collabEMAS Pharma · collabManchester University NHS Foundation Trust · collabMedical Matters International Ltd · collabSheffield Teaching Hospitals NHS Foundation Trust · collabSimbec Research · collabVoet Consulting · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2016-11-03
- Primary completion
- 2018-10-04
- Completion
- 2018-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 120 mg | Oral |
| Subject | Testosterone | Small molecule | 200 mg | Oral |
| Comparator | Testosterone Undecanoate | Small molecule | 80 mg | — |