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NCT02504541 · ClinicalTrials.gov registry record · Phase 3
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
A Phase 3 study, sponsored by Antares Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
NCT02504541: Completed Phase 3 study, sponsored by Antares Pharma.
NCT02504541 is a Phase 3 study that has completed, run by Antares Pharma. The registered enrollment target is 133 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02504541, a Phase 3 study, has completed, sponsored by Antares Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
Study Summary
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
Primary Outcome
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)
Interventions
- COMBINATION_PRODUCT Testosterone enanthate auto-injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT02504541 record still lists
NCT02504541 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Testosterone enanthate auto-injector is the first listed.
NCT02504541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02504541 about?
NCT02504541 is a clinical study titled "Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism". Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
What is the current status of trial NCT02504541?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2015-07. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02504541?
The interventions under investigation include: Testosterone enanthate auto-injector (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT02504541?
This trial is sponsored by Antares Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02504541's enrollment target sits among peer trials
133 1588th of 2000 higher than 413 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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