Study of 3 Doses of ARD-0403 in Testosterone Deficient Men (ARD-0403-001)

Ardana Bioscience

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: ARD-0403

Study type: Interventional

Funder types: Industry

Identifiers

NCT00597051

ARD-0403-001

Details and patient eligibility

About

The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.

Enrollment: 42 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Testosterone deficiency
• Normal BMI

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: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind