Clinical TrialID 4772

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

NCT02159469

Hypogonadism

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
4772
Evidence Id
4772
Core Evidence Id
4772
Source Clinical Trial Id
4745
Herb2 Clinical Trial Id
HBCT004745
Nct Id
NCT02159469
Title
Subcutaneous Testosterone Replacement Efficacy and 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
150
Outcome Measure
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL), 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., 12 weeks
Sponsor Collaborator
Antares Pharma Inc.
Funded By
INDUSTRY
Location
Birmingham, Alabama, United States|Huntsville, Alabama, United States|Tucson, Arizona, United States|Burbank, California, United States|Torrance, California, United States|Upland, California, United States|Jacksonville, Florida, United States|Oviedo, Florida, United States|Lexington, Kentucky, United States|Shreveport, Louisiana, United States|Brookline, Massachusetts, United States|Methuen, Massachusetts, United States|Kansas City, Missouri, United States|Lawrenceville, New Jersey, United States|Albany, New York, United States|New York, New York, United States|Rochester, New York, United States|Franklin, Ohio, United States|Medford, Oregon, United States|Warwick, Rhode Island, United States|Mount Pleasant, South Carolina, United States|Nashville, Tennessee, United States|San Antonio, Texas, United States|Sugar Land, Texas, United States|West Valley City, Utah, United States|Norfolk, Virginia, United States|Richmond, Virginia, United States|Renton, Washington, United States
Other Id
QST-13-003
Start Date
2014-07
Primary Completion Date
2015-02
Completion Date
2015-11
First Posted
2014-06-10
Results First Posted
2018-01-09
Last Update Posted
2018-02-07
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02159469
Title Cn
Title En
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Bilingual Status
semi_complete