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Completed Phase 3 Interventional Results available

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

ClinicalTrials.gov ID: NCT03868059

Public ClinicalTrials.gov record NCT03868059. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

Study identification

NCT ID
NCT03868059
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Lipocine Inc.
Industry
Enrollment
138 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 29, 2018
Primary completion
Feb 18, 2019
Completion
Feb 20, 2019
Last update posted
Jun 9, 2021

2018 – 2019

United States locations

U.S. sites
16
U.S. states
9
U.S. cities
16
Facility City State ZIP Site status
Alabama Clinical Therapeutics Birmingham Alabama 35235
South Florida Medical Research Aventura Florida 33180
Clinical Research of South Florida Coral Gables Florida 33134
Neostart Corporation dba AGA Clinical Trials Hialeah Florida 33012
Jacksonville Impotence Treatment Center Jacksonville Florida 32223
Oviedo Medical Research, LLC Oviedo Florida 32765
Clinical Research Center of Florida Pompano Beach Florida 33060
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
Regional Urology Shreveport Louisiana 71106
AccuMed Research Associates Garden City New York 11530
Manhattan Medical Research Practice PLLC New York New York 10016
Aventiv Research, Inc. Columbus Ohio 43213
Prestige Clinical Research Franklin Ohio 45005
Clinical Research Associates, Inc. Nashville Tennessee 37203
Granger Medical Clinic West Valley City Utah 84096
Rainier Clinical Research Center Renton Washington 98057

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03868059, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 9, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03868059 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →