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

NCT03868059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-06-10

Study results available
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Summary

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.

Conditions

  • Hypogonadism, Male

Interventions

DRUG

LPCN 1021

LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

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
2018-04-30
Primary Completion
2019-02-19
Completion
2019-02-21
FDA Drug
Yes

Countries

  • United States

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 NCT03868059 on ClinicalTrials.gov