MedTrace Logo

Safety and Efficacy Trial of Testosterone Undecanoate

NCT01765179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-12-12

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.

Conditions

  • Male Hypogonadism

Interventions

DRUG

Oral testosterone undecanoate

Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

Sponsors & Collaborators

  • inVentiv Health Clinical

    collaborator OTHER

  • Clarus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Swerdloff, MD · Los Andgeles Biomedical Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

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 NCT01765179 on ClinicalTrials.gov