Trials / Completed
CompletedNCT02504541
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Antares Pharma Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
Detailed description
Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Testosterone enanthate auto-injector | Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2015-07-22
- Last updated
- 2018-03-30
- Results posted
- 2018-03-30
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02504541. Inclusion in this directory is not an endorsement.