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

Ardana Bioscience

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

Treatments: Drug: ARD-0403

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448955

ARD-0403-004

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)