Trial Outcomes & Findings for Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021) (NCT NCT03242408)

Last Updated: 2019-10-23

Results Overview

Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration \[Cavg\] in the normal range

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Following 24 days of treatment

Results posted on

2019-10-23

Participant milestones
Measure	Oral Testosterone Undecanoate, LPCN 1021 Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate
Overall Study STARTED	100
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)

Baseline characteristics by cohort
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=100 Participants Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	54.1 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants
Baseline Testosterone Value (ng/dL)	189 ng/dL STANDARD_DEVIATION 72.4 • n=5 Participants

Timeframe: Following 24 days of treatment

Population: Safety Set

Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration \[Cavg\] in the normal range

Outcome measures
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=100 Participants Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate
Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range	69 Percent of participants Interval 60.0 to 78.0

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=100 participants at risk Oral testosterone undecanoate, LPCN 1021 150 mg TU three times a day LPCN 1021: Oral testosterone undecanoate
Metabolism and nutrition disorders Edema Peripheral	2.0% 2/100 • Number of events 2 • 1 month
Gastrointestinal disorders Dyspepsia	1.0% 1/100 • Number of events 1 • 1 month
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • 1 month
Nervous system disorders Hyperhidrosis	1.0% 1/100 • Number of events 1 • 1 month
Skin and subcutaneous tissue disorders Skin Ulcer	1.0% 1/100 • Number of events 1 • 1 month
Infections and infestations Respiratory tract infection	1.0% 1/100 • Number of events 1 • 1 month
Gastrointestinal disorders Tooth Fracture	1.0% 1/100 • Number of events 1 • 1 month
Nervous system disorders Presyncope	1.0% 1/100 • Number of events 1 • 1 month
Hepatobiliary disorders Hypertension	1.0% 1/100 • Number of events 1 • 1 month

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