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

A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562731

Acronym

ARD-0403-010

Enrollment

150

Registered

2007-11-22

Start date

2007-10-31

Completion date

2008-06-30

Last updated

2008-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Brief summary

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.

Interventions

DRUGARD-0403

Daily transdermal ARD-0403

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
Efficacy	Study Duration

Secondary

Measure	Time frame
Safety and Tolerability	Study Duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026