Open-Label Study of ARD-0403 in Testosterone Deficient Men

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardana Bioscience Ltd
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Testosterone deficiency

• Completed study ARD-0403-004

Exclusion Criteria:

• Previous treatment with testosterone replacement therapy within 4 weeks

• Moderate-severe benign prostatic hypertrophy or prostatic cancer

• Haematocrit >50%