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Clinical Trials/NCT00448955
NCT00448955
Completed
Phase 3

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

Ardana Bioscience Ltd12 sites in 1 country150 target enrollmentMay 2007
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ConditionsHypogonadism
DrugsARD-0403

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypogonadism
Sponsor
Ardana Bioscience Ltd
Enrollment
150
Locations
12
Primary Endpoint
Pharmacokinetic
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
February 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Eligibility Criteria

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%

Outcomes

Primary Outcomes

Pharmacokinetic

Secondary Outcomes

  • Safety and tolerability

Study Sites (12)

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