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Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism

NCT02081300 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2017-10-23

No results posted yet for this study

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, LPCN 1021

DRUG

Topical testosterone gel 1.62 %

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • PPD Development, LP

    collaborator INDUSTRY

  • Lipocine Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony DelConte, MD · Chief Medical Director, Lipocine, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT02081300 on ClinicalTrials.gov