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

Hypogonadism Clinical Trial

— ARD-0403-001  

Official title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Centre Study of the Pharmacokinetics and Tolerability of 3 Different Doses of ARD-0403 in Testosterone Deficient Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597051
• Other study ID #: ARD-0403-001
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2008
• Last updated: January 16, 2008
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: January 2008
• Source: Ardana Bioscience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• ARD-0403

Locations

Country	Name	City	State
Belarus	Republican Endocrinology Center Hospital	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
Ardana Bioscience Ltd

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic