Study of 3 Doses of ARD-0403 in Testosterone Deficient Men

Phase 2

Completed

• Conditions: Hypogonadism

• Registration Number: NCT00597051
• Lead Sponsor: Ardana Bioscience Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Last Update Submitted: 2008-01-16
• Study First Posted: 2008-01-17
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic

Trial Locations

Locations (1)

Republican Endocrinology Center Hospital; 🇧🇾 Minsk, Belarus