Trial Outcomes & Findings for Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (NCT NCT02159469)
NCT ID: NCT02159469
Last Updated: 2018-02-07
Results Overview
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-02-07
Participant Flow
Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).
The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
Participant milestones
| Measure |
QST 50 mg / 75 mg / 100 mg
Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
Completed 12 Week
|
137
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
QST 50 mg / 75 mg / 100 mg
Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
|
|---|---|
|
Overall Study
Missing Completion status
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Non-compliance
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Sponsor's request
|
2
|
|
Overall Study
Met Stopping Criteria
|
3
|
|
Overall Study
Other
|
1
|
|
Overall Study
Multiple
|
29
|
Baseline Characteristics
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Baseline characteristics by cohort
| Measure |
Testosterone Enanthate Auto-injector
n=150 Participants
Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Testosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg
|
|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 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
|
4 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Outcome measures
| Measure |
Testosterone Enanthate Auto-injector
n=150 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.
|
|---|---|
|
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
|
139 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.
* Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study
Outcome measures
| Measure |
Testosterone Enanthate Auto-injector
n=150 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.
|
|---|---|
|
Safety and Tolerability
Patients with any TEAE
|
125 Participants
|
|
Safety and Tolerability
Patients with any TEAE related to IP
|
66 Participants
|
|
Safety and Tolerability
Patients with any SAE
|
3 Participants
|
|
Safety and Tolerability
Patients with TEAE leading to discontinuation
|
30 Participants
|
|
Safety and Tolerability
Patients discontinued due to IP related TEAE
|
1 Participants
|
|
Safety and Tolerability
Patients with any adverse event leading to death
|
1 Participants
|
Adverse Events
Testosterone Enanthate Auto-injector
Serious events: 3 serious events
Other events: 125 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Testosterone Enanthate Auto-injector
n=150 participants at risk
Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg
|
|---|---|
|
Psychiatric disorders
Depression
|
0.67%
1/150 • Number of events 1 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Psychiatric disorders
Suicide
|
0.67%
1/150 • Number of events 1 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.67%
1/150 • Number of events 1 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
Other adverse events
| Measure |
Testosterone Enanthate Auto-injector
n=150 participants at risk
Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Testosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg
|
|---|---|
|
Investigations
Hematocrit increased
|
14.0%
21/150 • Number of events 21 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Investigations
Prostatic specific antigen increased
|
12.0%
18/150 • Number of events 18 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.3%
5/150 • Number of events 5 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Investigations
Blood testosterone increased
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
12/150 • Number of events 12 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Sinusitis
|
7.3%
11/150 • Number of events 11 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
6/150 • Number of events 6 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Bronchitis
|
3.3%
5/150 • Number of events 5 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Influenza
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
General disorders
Injection site bruising
|
6.7%
10/150 • Number of events 10 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Gastrointestinal disorders
Injection site hemorrhage
|
3.3%
5/150 • Number of events 5 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
General disorders
Injection site erythema
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
General disorders
Edema peripheral
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
General disorders
Fatigue
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Vascular disorders
Hypertension
|
12.7%
19/150 • Number of events 19 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
5/150 • Number of events 5 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Nervous system disorders
Headache
|
5.3%
8/150 • Number of events 8 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.7%
4/150 • Number of events 4 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
|
Blood and lymphatic system disorders
Polycythemia
|
2.0%
3/150 • Number of events 3 • Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 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. In total, 125 (83.3%) patients had TEAEs during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER