Trial Outcomes & Findings for Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism (NCT NCT02504541)
NCT ID: NCT02504541
Last Updated: 2018-03-30
Results Overview
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
133 participants
Primary outcome timeframe
26 weeks
Results posted on
2018-03-30
Participant Flow
133 patients were enrolled in this study. 113 (85.0%) patients completed the study (through the Follow-up Visit) and 20 (15.0%) patients prematurely withdrew from the study.
Although 21 sites participated in the study, only 19 sites enrolled patients in the United States. This study was intended to collect additional safety and exposure data, to ensure compliance and accuracy.
Participant milestones
| Measure |
Testosterone Enanthate Auto-injector
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Overall Study
STARTED
|
133
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Testosterone Enanthate Auto-injector
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Met Stopping Criteria
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Termination by Sponsor
|
1
|
|
Overall Study
Other
|
2
|
|
Overall Study
Multiple
|
5
|
Baseline Characteristics
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Baseline characteristics by cohort
| Measure |
Testosterone Enanthate Auto-injector
n=133 Participants
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.30 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 26 weeksNumber of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population. Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
Outcome measures
| Measure |
Testosterone Enanthate Auto-injector
n=133 Participants
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Patients with any TEAE
|
87 Participants
|
|
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Patients with any TEAE related to QST
|
34 Participants
|
|
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Patients with SAE
|
4 Participants
|
|
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Patients with TEAE leading to Discontinuation
|
8 Participants
|
|
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Patients with QST related TEAE and discontinuation
|
4 Participants
|
Adverse Events
Testosterone Enanthate Auto-injector
Serious events: 4 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Enanthate Auto-injector
n=133 participants at risk
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Eye disorders
Visual Impairment
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Infections and infestations
APPENDICITIS
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIC RESPIRATORY FAILURE
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Infections and infestations
RIGHT KNEE SEPTIC ARTHRITIS
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Cardiac disorders
PRINZMETAL ANGINA
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.75%
1/133 • Number of events 1 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
Other adverse events
| Measure |
Testosterone Enanthate Auto-injector
n=133 participants at risk
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
10/133 • Number of events 10 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
5/133 • Number of events 5 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
4/133 • Number of events 4 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Investigations
Hematocrit increased
|
8.3%
11/133 • Number of events 11 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.8%
5/133 • Number of events 5 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Investigations
PSA increased
|
3.0%
4/133 • Number of events 4 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
General disorders
Injection site hemorrhage
|
6.0%
8/133 • Number of events 8 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
General disorders
Injection site bruising
|
3.8%
5/133 • Number of events 5 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
General disorders
Fatigue
|
2.3%
3/133 • Number of events 3 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
3/133 • Number of events 3 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Reproductive system and breast disorders
Prostatitis
|
3.0%
4/133 • Number of events 4 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Psychiatric disorders
Insomnia
|
2.3%
3/133 • Number of events 3 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
|
Vascular disorders
Hypertension
|
2.3%
3/133 • Number of events 3 • 26 Weeks
Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER