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Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT01403116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2018-08-14

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Conditions

  • Male Hypogonadism

Interventions

DRUG

Oral testosterone undecanoate

Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

DRUG

topical testosterone gel

Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

Sponsors & Collaborators

  • PharmaNet

    collaborator INDUSTRY

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • Clarus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Swerdloff, MD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Germany

Study Locations

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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 NCT01403116 on ClinicalTrials.gov