Trials / Completed
CompletedNCT02777242
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
An Open-Label Study to Evaluate the Safety of Testosterone Enanthate After Two Single-Dose Injections Via QuickShot® Testosterone by Intended Users and QuickShot™ Summative Usability Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Antares Pharma Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the safety and tolerability of testosterone enanthate (TE) following a single dose via QuickShot® Testosterone (QST) when administered by intended users in a usability study.
Detailed description
Intended users are patients as well as patient caregivers, such as family members or friends who are able to assist the patient to administer the medication (i.e. lay users). One user group of approximately 15 patients will have their dose administered by a qualified healthcare professional (HCP).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Testosterone enanthate auto-injector | SC injections of QST 50 mg or 75 mg or 100 mg |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2016-05-19
- Last updated
- 2018-03-22
- Results posted
- 2018-02-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02777242. Inclusion in this directory is not an endorsement.