The safety and effectiveness of testosterone pellet implantation in hypogonadal males
An Open-Label Study to Characterize the Pharmacokinetics, Effectiveness, and Safety of Subcutaneous Implantation of 12 Testosterone Pellets (AA3000 75mg) in Hypogonadal Males
Auxilium Pharmaceuticals, Inc.
24 participants
Jul 11, 2014
Interventional
Conditions
Summary
This trial aims to study the pharmacokinetics, effectiveness and safety of 12 pellets of 75mg testosterone (900mg total) implanted under the skin in males who have hypogonadism. Testosterone replacement therapy may help to restore male secondary characteristics, sexual behaviour, energy, mood and muscle development. This trial will enrol 24 male participants between the ages of 18-70 who have blood testosterone levels below 300ng/dL. All participants will undergo a screening visit 21 days prior to check for eligibility. Eligible participants will undergo an implantation procedure where 12 testosterone pellets will be implanted under the skin. Blood samples will be collected at various timepoints throughout the trial for pharmacokinetic analysis and safety parameters. Participants will also complete a series of questionnaires throughout the trial. Participants will be followed up for 113 days.
Eligibility
Inclusion Criteria5
- Male
- Serum testosterone level of less than 300ng/dL
- Body mass index between 20 and 40
- Be in good general health otherwise
- Able to complete questionnaires
Exclusion Criteria18
- History of allergy or hypersensitivity to the study medication
- History of alcoholism or substance abuse
- History of chronic use of medications such as glucocorticoids
- Previous use or planned use during the study of testosterone products (long acting depot products within 6 months, short acting injectables within 6 weeks, topical or oral products within 14 days before the screening visit)
- Use of medications that may interfere with androgen metabolism (e.g. spironolactone, cimetidine, 5a-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products) within 4 weeks of screening visit or plans to use these during the study.
- History of myocardial infarction, unstable angina, heart failure including congestive heart failure, or ventricular dysrhythmia
- History of venous thromboembolic disease (eg, deep vein thrombosis or pulmonary embolism).
- Uncontrolled hypertension
- Uncontrolled diabetes
- Significant cerebrovascular disease
- History of HIV
- History of polycythemia or erythyrocytosis
- Prostate cancer or a history of prostate cancer
- Serum prostate specific antigen (PSA) level greater than or equal to 4 ng/mL
- Breast cancer
- Liver disease
- Hyperparathyroidism
- Received investigational drug within 30 days before screening visit.
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Interventions
12 pellets each containing 75mg (total dose 900mg) of testosterone will be implanted under the skin of the side of the buttocks. The local area will be cleaned with antiseptic and local anesthetic injected. A small cut will be made and the testosterone pellets inserted under the skin using an applicator device called a trocar. Adhesive strips will be applied to close the insertion site and dressing to cover the area. The pellets remain in situ and dissolve over time. If a situation arises that necessitates discontinuation of testosterone, the pellets must be surgically removed.
Locations(1)
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ACTRN12614000604606