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

Information source: Antares Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testosterone enanthate auto-injector (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Antares Pharma Inc.

Official(s) and/or principal investigator(s):
Jed Kaminetsky, MD, Principal Investigator, Affiliation: Manhattan Medical Research Practice


Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Clinical Details

Official title: A Double-blind, Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of patients with Total Testosterone Cavg(0-168h) serum concentrations within the normal range (300-1100 ng/dL)

Secondary outcome:

Percentage of patients with Total Testosterone serum Cmax < 1500 ng/dL, Cmax 1800-2500 ng/dL and Cmax >2500 ng/dL

Maximum and minimum Total Testosterone serum concentrations following dose administration at week 12

Number of patients with Total Testosterone serums concentrations > 1500ng/dL and <300 ng/dl on days 1, 2, 3, 4 and 8 following dose administration at week 12

Detailed description: This study will evaluate if testosterone enanthate administered subcutaneously once each week by an auto injector to men with low testosterone can raise their levels into the normal range. The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations. Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto injector and follow the instructions for auto injector use. Patient satisfaction with sexual functioning will also be assessed during this 52 week study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Adult males aged ≥ 18 year of age with a documented diagnosis 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 PSA for age.

- Abnormal DRE

- Obstructive uropathy of prostatic origin

- Poorly controlled diabetes

- Congestive heart failure

- Within 6 months of screening, MI, unstable angina leading to hospitalization,

percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.

- History or current treatment of thromboembolic disease.

- Use of 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, 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 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

Locations and Contacts

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Tucson 1, Arizona, United States

Tucson 2, 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

Sugarland, Texas, United States

West Valley City, Utah, United States

Norfolk 1, Virginia, United States

Norfolk 2, Virginia, United States

Richmond, Virginia, United States

Renton, Washington, United States

Additional Information

Starting date: July 2014
Last updated: July 20, 2015

Page last updated: August 23, 2015

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