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Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

NCT03242590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2019-10-23

Study results available
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Summary

Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.

Conditions

  • Hypogonadism, Male

Interventions

DRUG

LPCN 1021

Oral testosterone undecanoate

Sponsors & Collaborators

  • Lipocine Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony DelConte, MD · Lipocine Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-03-31
Completion
2017-07-31
FDA Drug
Yes

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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 NCT03242590 on ClinicalTrials.gov