Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

March 29, 2018 updated by: Antares Pharma Inc.

A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • San Diego, California, United States
    • Florida
      • Aventura, Florida, United States
      • Brandon, Florida, United States
      • Jacksonville, Florida, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Elkridge, Maryland, United States
    • New York
      • Garden City, New York, United States
      • New York, New York, United States
    • Ohio
      • Columbus, Ohio, United States
      • Franklin, Ohio, United States
    • Oregon
      • Medford, Oregon, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greer, South Carolina, United States
    • Texas
      • Hurst, Texas, United States
    • Utah
      • West Valley City, Utah, United States
    • Washington
      • Olympia, Washington, United States
      • Renton, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
  • Total testosterone levels < 300 ng/dL at two qualification visits
  • Patients in good general health

Exclusion Criteria:

  • Allergy to sesame or testosterone products
  • BMI ≥ 40 kg/m2
  • Hematocrit ≥ 52%
  • History or current evidence of breast or prostate cancer
  • Elevated prostate-specific antigen (PSA) for age.
  • Abnormal digital rectal examination (DRE)
  • Unstable psychiatric illnesses
  • Obstructive uropathy of prostatic origin
  • Poorly controlled diabetes
  • Congestive heart failure
  • Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
  • History or current treatment of thromboembolic disease.
  • Use of adrenocorticotropic hormone (ACTH) or oral/depot corticosteroids within 6 weeks of screening.
  • History of severe, untreated sleep apnea
  • Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
  • Positive serology for HIV, hepatitis B or hepatitis C
  • Current evidence of drug or alcohol abuse.
  • Skin conditions in injection site that could confound injection site assessments.
  • Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
  • Use of estrogen, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening.
  • Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) of testosterone enanthate
  • Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
  • Donation of plasma or blood within 56 days of screening or history of donation of > 50 mL of blood or plasma within 3 months of screening.
  • Donation of plasma or blood during study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone enanthate auto-injector
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.
Combination product: Testosterone enanthate auto-injector
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Other Names:
  • Testosterone
  • Testosterone enanthate
  • QuickShot® Testosterone (QST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Time Frame: 26 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antares Pharma Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QST-15-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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