Efficacy, Pharmacokinetics and Safety of Testosterone

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Ages 18-65

• History of hypogonadism

• In good health based on medical history, physical examination and clinical laboratory tests

• Screening morning serum testosterone ≤ 297 ng/dL

• One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)

• Body mass index (BMI) between 18 and 31

Exclusion Criteria:

• Prostate cancer

• Palpable prostatic mass(es)

• Generalized skin irritation or significant skin disease

• Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)

• Clinically significant anemia or renal dysfunction

• Hyperparathyroidism or uncontrolled diabetes

• Serum PSA Levels; ≥ 4ng/mL

• History of cardiovascular disease

• Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)

• Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)