The safety and effectiveness of testosterone pellet implantation in hypogonadal males

Phase 2

Completed

• Conditions: Hypogonadism; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12614000604606
• Lead Sponsor: Auxilium Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. Male
2. Serum testosterone level of less than 300ng/dL
3. Body mass index between 20 and 40
4. Be in good general health otherwise
5. Able to complete questionnaires

Exclusion Criteria

1. History of allergy or hypersensitivity to the study medication
2. History of alcoholism or substance abuse
3. History of chronic use of medications such as glucocorticoids
4. 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)
5. 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.
6. History of myocardial infarction, unstable angina, heart failure including congestive heart failure, or ventricular dysrhythmia
7. History of venous thromboembolic disease (eg, deep vein thrombosis or pulmonary embolism).
8. Uncontrolled hypertension
9. Uncontrolled diabetes
10. Significant cerebrovascular disease
11. History of HIV
12. History of polycythemia or erythyrocytosis
13. Prostate cancer or a history of prostate cancer
14. Serum prostate specific antigen (PSA) level greater than or equal to 4 ng/mL
15. Breast cancer
16. Liver disease
17. Hyperparathyroidism
18. Received investigational drug within 30 days before screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified