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

• Status: Completed
• Trial end date: 2008-02-01
• 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 wellbeing. 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

Exclusion Criteria:

• Previous treatment with testosterone replacement therapy within 4 weeks

• Moderate-severe benign prostatic hypertrophy, or prostatic cancer

• Haematocrit >50%