Trial · NCT02159469
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
NCT02159469, Phase 3, Completed, Antares Pharma Inc.; results first posted 2018-01-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism. Trials, record NCT02159469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02159469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
- NCT number
- NCT02159469
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Antares Pharma Inc.
- Conditions
- Hypogonadism
- Interventions
- Testosterone enanthate auto-injector
- First posted
- 2014-06-10
- Last updated
- 2018-02-07
- Results first posted
- 2018-01-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | 12 weeks | 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. |
| Secondary | Safety and Tolerability | 52 weeks | * Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability | 52 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | Testosterone Enanthate Auto-injector | 139 | Participants | ||
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients with any TEAE | 125 | Participants | |
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients with any TEAE related to IP | 66 | Participants | |
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients with any SAE | 3 | Participants | |
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients with TEAE leading to discontinuation | 30 | Participants | |
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients discontinued due to IP related TEAE | 1 | Participants | |
| Safety and Tolerability | Testosterone Enanthate Auto-injector | Patients with any adverse event leading to death | 1 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QST 50 mg / 75 mg / 100 mg | 150 | |
| Overall Study | Completed 12 Week | QST 50 mg / 75 mg / 100 mg | 137 | |
| Overall Study | COMPLETED | QST 50 mg / 75 mg / 100 mg | 97 | |
| Overall Study | NOT COMPLETED | QST 50 mg / 75 mg / 100 mg | 53 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hematocrit increased | Investigations | Testosterone Enanthate Auto-injector | 21 | 150 | 21 |
| other | Prostatic specific antigen increased | Investigations | Testosterone Enanthate Auto-injector | 18 | 150 | 18 |
| other | Blood creatine phosphokinase increased | Investigations | Testosterone Enanthate Auto-injector | 5 | 150 | 5 |
| other | Blood testosterone increased | Investigations | Testosterone Enanthate Auto-injector | 4 | 150 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Testosterone Enanthate Auto-injector | 12 | 150 | 12 |
| other | Sinusitis | Infections and infestations | Testosterone Enanthate Auto-injector | 11 | 150 | 11 |
| other | Nasopharyngitis | Infections and infestations | Testosterone Enanthate Auto-injector | 6 | 150 | 6 |
| other | Bronchitis | Infections and infestations | Testosterone Enanthate Auto-injector | 5 | 150 | 5 |
| other | Influenza | Infections and infestations | Testosterone Enanthate Auto-injector | 4 | 150 | 4 |
| other | Urinary tract infection | Infections and infestations | Testosterone Enanthate Auto-injector | 4 | 150 | 4 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testosterone Enanthate Auto-injector | 1 | 150 |
| Total, other adverse events | Testosterone Enanthate Auto-injector | 125 | 150 |
| Total, serious adverse events | Testosterone Enanthate Auto-injector | 3 | 150 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02159469
GET https://conductscience.org/api/trials/v1/NCT02159469/events?page=2