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Hormone Therapy
Testosterone enanthate auto-injector for Low Testosterone
Phase 3
Waitlist Available
Led By Gary Bedel, MD
Research Sponsored by Antares Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Summary
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Side effects data
From 2015 Phase 3 trial • 150 Patients • NCT0215946914%
Hematocrit increased
13%
Hypertension
12%
Prostatic specific antigen increased
8%
Upper respiratory tract infection
7%
Sinusitis
7%
Injection site bruising
5%
Headache
4%
Nasopharyngitis
3%
Bronchitis
3%
Edema peripheral
3%
Injection site hemorrhage
3%
Injection site erythema
3%
Back pain
3%
Blood creatine phosphokinase increased
3%
Blood testosterone increased
3%
Influenza
3%
Urinary tract infection
3%
Acne
3%
Prostatitis
3%
Cough
2%
Eczema
2%
Fatigue
2%
Sinus congestion
2%
Polycythemia
2%
Hemorrhoids
2%
Hematuria
2%
Sleep apnea syndrome
2%
Abdominal pain
2%
Arthralgia
1%
Vertigo
1%
Suicide
1%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testosterone Enanthate Auto-injector
Trial Design
1Treatment groups
Experimental Treatment
Group I: Testosterone enanthate auto-injectorExperimental Treatment1 Intervention
Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone enanthate
FDA approved
Find a Location
Who is running the clinical trial?
Antares Pharma Inc.Lead Sponsor
10 Previous Clinical Trials
1,101 Total Patients Enrolled
Gary Bedel, MDPrincipal InvestigatorPrestige Clinical Research
1 Previous Clinical Trials
39 Total Patients Enrolled
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