MedTrace Logo

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

NCT02966652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-11-26

No results posted yet for this study

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.

Conditions

  • Male Hypogonadism

Interventions

DRUG

DITEST

Lipid formulation of native oral testosterone.

DRUG

Testosterone undecanoate

Generic treatment for patients with primary or secondary male hypogonadism

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    collaborator OTHER

  • Simbec Research

    collaborator INDUSTRY

  • Voet Consulting

    collaborator INDUSTRY

  • EMAS Pharma

    collaborator INDUSTRY

  • Medical Matters International Ltd

    collaborator INDUSTRY

  • Brush Clinical Research Ltd.

    collaborator INDUSTRY

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Covance

    collaborator INDUSTRY

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • J Newell-Price, MA, PhD · University of Sheffield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2018-10-04
Completion
2018-10-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966652 on ClinicalTrials.gov