Open-Label Study of ARD-0403 in Testosterone Deficient Men

Phase 3TerminatedNCT00562731

Ardana Bioscience Ltd150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Hypogonadism

Interventions

ARD-0403DRUG

Daily transdermal ARD-0403

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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%

Locations (12)

Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States

Stanford University

Stanford, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Outcomes

Primary Outcomes

Efficacy

Time frame: Study Duration

Secondary Outcomes

Safety and Tolerability

Time frame: Study Duration

Data from ClinicalTrials.gov

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