Trial Outcomes & Findings for Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). (NCT NCT03242590)

Last Updated: 2019-10-23

Results Overview

The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

95 participants

Primary outcome timeframe

Following 24 days of treatment

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Testosterone Undecanoate, LPCN 1021 Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Overall Study STARTED	95
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=95 Participants Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Age, Continuous	56.0 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	95 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	15 Participants n=5 Participants
Race (NIH/OMB) White	77 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	95 participants n=5 Participants
Baseline Testosterone Value (ng/dL)	202 ng/dL STANDARD_DEVIATION 74.5 • n=5 Participants

PRIMARY outcome

Timeframe: Following 24 days of treatment

Population: Safety Set

Outcome measures

Outcome measures
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=95 Participants Oral testosterone undecanoate, LPCN 1021 225 mg TU two 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	80 Percent of participants Interval 72.0 to 88.0

Adverse Events

Oral Testosterone Undecanoate, LPCN 1021

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=95 participants at risk Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Gastrointestinal disorders Gastric Ulcer Hemorrhage	1.1% 1/95 • Number of events 1 • 1 month

Other adverse events

Other adverse events
Measure	Oral Testosterone Undecanoate, LPCN 1021 n=95 participants at risk Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
Endocrine disorders Blood prolactin increased	4.2% 4/95 • Number of events 4 • 1 month
Endocrine disorders Blood FSH decreased	1.1% 1/95 • Number of events 1 • 1 month
Endocrine disorders Blood LH decreased	1.1% 1/95 • Number of events 1 • 1 month
Investigations PSA increased	1.1% 1/95 • Number of events 1 • 1 month
Investigations Weight increased	1.1% 1/95 • Number of events 1 • 1 month
Nervous system disorders Headache	1.1% 1/95 • Number of events 1 • 1 month

Additional Information

Nachiappan Chidambaram, Vice President, Product Development

Lipocine, INC.

Phone: 8018819495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER