NCT03868059

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Lipocine Inc. · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	LPCN 1021	LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.

Timeline

• Start date: 2018-04-30
• Primary completion: 2019-02-19
• Completion: 2019-02-21
• First posted: 2019-03-08
• Last updated: 2021-06-10
• Results posted: 2021-06-10

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study