Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
NCT03868059 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG LPCN 1021
Study Locations (16)
Florida
- South Florida Medical Research — Aventura
- Clinical Research of South Florida — Coral Gables
- Neostart Corporation dba AGA Clinical Trials — Hialeah
- Jacksonville Impotence Treatment Center — Jacksonville
- Oviedo Medical Research, LLC — Oviedo
- Clinical Research Center of Florida — Pompano Beach
New York
- AccuMed Research Associates — Garden City
- Manhattan Medical Research Practice PLLC — New York
Ohio
- Aventiv Research, Inc. — Columbus
- Prestige Clinical Research — Franklin
Alabama
- Alabama Clinical Therapeutics — Birmingham
Kentucky
- Central Kentucky Research Associates, Inc. — Lexington
Louisiana
- Regional Urology — Shreveport
Tennessee
- Clinical Research Associates, Inc. — Nashville
Utah
- Granger Medical Clinic — West Valley City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2019-02-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03868059
The ClinicalTrials.gov registry entry for NCT03868059 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lipocine, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypogonadism, Male appearing as the primary indexed condition, and to 1 intervention — of which LPCN 1021 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03868059 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Florida, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03868059 about?
NCT03868059 is a clinical study titled "Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men". 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.
What is the current status of trial NCT03868059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 138 participants. The study started on 2018-04-30. Estimated completion is 2019-02-21.
What conditions does trial NCT03868059 study?
This clinical trial studies the following conditions: Hypogonadism, Male. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03868059?
The interventions under investigation include: LPCN 1021 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03868059?
This trial is sponsored by Lipocine, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03868059 being conducted?
This trial has 16 study locations across Alabama, Florida, Kentucky, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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