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

A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00448955

Enrollment

150

Registered

2007-03-19

Start date

2007-05-31

Completion date

2008-02-29

Last updated

2008-04-18

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 wellbeing. 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

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

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
Pharmacokinetic	—

Secondary

Measure	Time frame
Safety and tolerability	—

Countries

United States

Outcome results

None listed

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