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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
South Florida Medical Research
Aventura, Florida, United States
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Time frame: Baseline to end of study (approximately 4 months).
Change in ABPM-measured Average Daytime SBP
Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime SBP
Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime DBP
Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime DBP
Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Research of South Florida
Coral Gables, Florida, United States
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Regional Urology
Shreveport, Louisiana, United States
AccuMed Research Associates
Garden City, New York, United States
...and 6 more locations
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime PR
Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime PR
Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning SBP Measured in Triplicate at the Clinic
Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning DBP Measured in Triplicate at the Clinic
Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning PR Measured in Triplicate at the Clinic
Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5
Time frame: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Distress
Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)
Time frame: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Desire
Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)
Time frame: Baseline to End of Study (approximately 4 months)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)