Clinical TrialID 4781
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
NCT02504541
Hypogonadism
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 4781
- Evidence Id
- 4781
- Core Evidence Id
- 4781
- Source Clinical Trial Id
- 4754
- Herb2 Clinical Trial Id
- HBCT004754
- Nct Id
- NCT02504541
- Title
- Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Hypogonadism
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- COMBINATION_PRODUCT: Testosterone enanthate auto-injector
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 133
- Outcome Measure
- Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism, 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), 26 weeks
- Sponsor Collaborator
- Antares Pharma Inc.
- Funded By
- INDUSTRY
- Location
- Birmingham, Alabama, United States|Mobile, Alabama, United States|Tucson, Arizona, United States|San Diego, California, United States|Aventura, Florida, United States|Brandon, Florida, United States|Jacksonville, Florida, United States|Shreveport, Louisiana, United States|Elkridge, Maryland, United States|Garden City, New York, United States|New York, New York, United States|Columbus, Ohio, United States|Franklin, Ohio, United States|Medford, Oregon, United States|Charleston, South Carolina, United States|Greer, South Carolina, United States|Hurst, Texas, United States|West Valley City, Utah, United States|Olympia, Washington, United States|Renton, Washington, United States
- Other Id
- QST-15-005
- Start Date
- 2015-07
- Primary Completion Date
- 2016-06
- Completion Date
- 2016-06
- First Posted
- 2015-07-22
- Results First Posted
- 2018-03-30
- Last Update Posted
- 2018-03-30
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02504541
- Title Cn
- Title En
- Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
- Bilingual Status
- semi_complete