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

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

Completed

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Republican Endocrinology Center Hospital

Minsk, 220 007, Belarus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ARD-0403

Drug

Primary outcomes

Pharmacokinetic

Sponsors and collaborators

Lead sponsor

Ardana Bioscience Ltd

Industry

Registry information

Official study 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

Acronym: ARD-0403-001

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Jan 17, 2008
Registry last updated: Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed