Open-Label Study of ARD-0403 in Testosterone Deficient Men (ARD-0403-010)

Ardana Bioscience

Status and phase: Terminated; Phase 3

Conditions: Hypogonadism

Treatments: Drug: ARD-0403

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562731

ARD-0403-010

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 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)