At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 138 enrolled
Drug / intervention
LPCN 1021drug
Likely dose
LPCN 1021 112.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
In Brief
A Phase 3 clinical trial evaluating LPCN 1021 for Hypogonadism, Male. Completed, enrolled 138 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Male
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartApr 2018
Primary CompletionFeb 2019
Study CompletionFeb 2019
First PostedMar 2019
TodayJul 2026
First PostedMar 8, 2019
Enrollment StartApr 30, 2018
Primary CompletionFeb 19, 2019
Study CompletionFeb 21, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.3 years ago
Interventions
LPCN 1021drug
LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.