Trial Outcomes & Findings for A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial (NCT NCT04685993)
NCT ID: NCT04685993
Last Updated: 2024-07-17
Results Overview
Number of subjects presenting with a treatment-emergent adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline to Week 36
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Treatment A
LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered twice daily (225 mg testosterone undecanoate per dose).
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
Baseline characteristics by cohort
| Measure |
Treatment A
n=25 Participants
LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 36Number of subjects presenting with a treatment-emergent adverse events
Outcome measures
| Measure |
Treatment A
n=25 Participants
LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
|
|---|---|
|
Safety and Tolerability of LPCN 1144
|
10 Participants
|
Adverse Events
Treatment A
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment A
n=25 participants at risk
LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
1/25 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Treatment A
n=25 participants at risk
LPCN 1144: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
|
|---|---|
|
Infections and infestations
Upper respiratory infection
|
8.0%
2/25 • Number of events 2 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or twelve months after the completion of the study, whichever occurs first, the PI may itself publish the results of its data from the study. The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least sixty days prior to the planned date of submission.
- Publication restrictions are in place
Restriction type: OTHER