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NCT03868059 · ClinicalTrials.gov registry record · Phase 3
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
A Phase 3 study of Hypogonadism, Male, sponsored by Lipocine.
- Completed
- Registry status
- Phase 3
- Development phase
- 138
- Enrollment target
- 16
- Study locations
NCT03868059: Completed Phase 3 study of Hypogonadism, Male, sponsored by Lipocine.
NCT03868059 is a Phase 3 study of Hypogonadism, Male that has completed, run by Lipocine. The registered enrollment target is 138 participants, above the 101-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target (37% higher). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03868059, a Phase 3 study of Hypogonadism, Male, has completed, sponsored by Lipocine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 138 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
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 |
What the finished NCT03868059 record still lists
NCT03868059 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, above the 101-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target (37% higher).
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.
NCT03868059 lists 16 locations in 9 states (Florida, New York, Ohio).
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.
What interventions are being tested in trial NCT03868059?
The interventions under investigation include: LPCN 1021 (DRUG).
Who is sponsoring clinical trial NCT03868059?
This trial is sponsored by Lipocine, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hypogonadism, Male
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03868059's enrollment target sits among peer trials
138 4th of 12 higher than 9 of 12 other Hypogonadism, Male trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism, Male trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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