Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

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

Summary

Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

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

Details

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

Criteria

Inclusion Criteria:

• Male, 18 - 65 years of age;

• Documented testosterone deficiency;

• BMI 18 to 33.

Exclusion Criteria:

• Evidence of prostate cancer and benign prostate hyperplasia;

• Taking medications that interfere testosterone metabolism;

• History of alcohol or drug substance abuse;

• Abnormal ECG;

• Allergic to transdermal products;

• Skin condition that interfere transdermal system application and assessment