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
Summary
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/dLMaximum 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
|
