Trial Outcomes & Findings for Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism (NCT NCT02777242)
NCT ID: NCT02777242
Last Updated: 2018-03-22
Results Overview
Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
3 weeks
Results posted on
2018-03-22
Participant Flow
In total, 66 patients were enrolled, of which 65 patients were randomized and were included in the Safety Population.
The Safety Population included all patients who were randomized and took at least one dose of Investigational Product. The Safety Population was used as the denominator in percentage calculations.
Participant milestones
| Measure |
Testosterone Enanthate Auto-injector
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Testosterone Enanthate Auto-injector
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]
|
|---|---|
|
Overall Study
Other
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Multiple
|
1
|
|
Overall Study
Sponsor's request
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
Baseline characteristics by cohort
| Measure |
Testosterone Enanthate Auto-injector
n=65 Participants
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]
|
|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksIntended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.
Outcome measures
| Measure |
Testosterone Enanthate Auto-injector
n=65 Participants
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]
|
|---|---|
|
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Patients with any TEAE
|
5 Participants
|
|
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Patients with any TEAE related to QST
|
1 Participants
|
|
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Patients with SAE
|
0 Participants
|
|
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Patients with TEAE leading to discontinuation
|
0 Participants
|
|
Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.
Patients with QST related TEAE and discontinuation
|
0 Participants
|
Adverse Events
Testosterone Enanthate Auto-injector
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Enanthate Auto-injector
n=65 participants at risk
Testosterone enanthate administered subcutaneously once each week via auto-injector of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]
|
|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
1.5%
1/65 • Number of events 1 • 3 Weeks
An adverse event was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to IP after randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER