Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism

NCT02777242 | Completed Phase 2 Results

• 1 other identifier: QST-16-006
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypogonadism

Keywords

Hypogonadism; Testosterone enanthate

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.

  Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.

  3 weeks

Study Arms (1)

Testosterone enanthate auto-injector

EXPERIMENTAL

Testosterone enanthate administered subcutaneously once each week. Auto-injection of QST 50 mg or 75 mg or 100 mg \[Device: QuickShot® Testosterone (QST)\]

Combination Product: Testosterone enanthate auto-injector

Interventions

Testosterone enanthate auto-injector COMBINATION_PRODUCT

SC injections of QST 50 mg or 75 mg or 100 mg

Also known as: Testosterone, Testosterone enanthate, QuickShot® Testosterone (QST)

Testosterone enanthate auto-injector

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each patient must meet all of the following criteria at screening to participate in the study:
• The patient is 18 years of age or older;
• The patient speaks, reads, and understands the English language at a sixth grade reading level or higher;
• The patient is willing to have photographs taken and/or be video recorded while he completes study tasks, which will be de-identified prior to any potential use of the image(s) for scientific or educational purposes;
• The patient has sufficient availability to participate in the study and to comply with the study schedule;
• The patient has his own transportation to and from the study site;
• The patient demonstrates the ability to understand and the willingness to follow all study instructions; and
• The patient has read, stated he understands, and has signed the Informed Consent Form (ICF).
• The patient has been diagnosed with hypogonadism;
• The patient is a male;
• The patient has a documented history of hypogonadism. Diagnosis must include documentation of consistent signs and symptoms of androgen deficiency;
• Patients in good health as determined by the Investigator and based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests;
• All male patients must practice effective contraception during the study and for 30 days after receiving the last dose of study drug. Acceptable methods of birth control include condom with spermicide, vasectomy, or monogamous relations with a female partner who is of non child-bearing potential (post-menopausal, surgical, or congenital sterility) or is of child bearing potential and practicing a reliable method of contraception (hormonal contraception, double barrier methods with spermicide, or intrauterine device); and
• Patients must have the ability to provide written informed consent and comply with all study requirements and restrictions including the study visit schedule.

You may not qualify if:

• Patients will be excluded from participation in the study if any of the following criteria apply:
• The patient has participated in interviews, focus groups, or studies for any medical products or therapies within the past 3 months or in a prior QST auto-injector usability study, clinical trial, and/or has previous exposure to the investigational device;
• The patient or someone he lives with works or has worked for a Marketing/Market Research Company, pharmaceutical or medical device company, a manufacturer, distributor, or wholesaler of non-prescription drug products, or a government health agency;
• Individuals who have had an allergic reaction or idiosyncratic reaction to sesame seeds, sesame products, and/or sesame oil;
• History of food anaphylaxis;
• History of intolerance, allergy, or idiosyncratic reaction to testosterone products;
• Unstable psychiatric illnesses;
• Lifetime history of psychosis, suicidal behavior, bipolar disorder, or personality disorder; active suicidal ideation within 6 months prior to screening; or inadequately treated depression. Note: Patients with depression who have been adequately treated and with stable response for 3 months may be admitted into the study at the Investigator's discretion;
• Body mass index 40 kg/m2;
• Hematocrit 52% at Initial Screening Visit;
• Individual history or current evidence of breast or prostate cancer;
• Other malignancy diagnosed or treated within 5 years of the date of Initial Screening Visit with the exception of non-melanoma carcinoma of the skin;
• Presence of prostate nodule or induration upon digital rectal exam;
• Obstructive uropathy of prostatic origin and of a severity that, in the opinion of the Investigator, contraindicates the use of testosterone;
• Patients with poorly controlled diabetes. Patients on a stable dose and regimen of anti diabetic medications for a minimum of 4 weeks, and who have a hemoglobin A1c level of 7.5% may participate in the study;

Sponsors & Collaborators

• Antares Pharma Inc.: lead

Study Sites (3)

Unknown Facility

Birmingham, Alabama, 35235, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; testosterone enanthate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Jonathan Jaffe, MD
• Organization: Antares Pharma, Inc.

jjaffe@antarespharma.com

609-359-3020

Study Officials

• Jed Kaminetsky, MD

  Manhattan Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 19, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 22, 2018
• Results First Posted: February 26, 2018

Record last verified: 2018-02

Locations

US (3)