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Clinical Trials/NCT00562731
NCT00562731
Terminated
Phase 3

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

Ardana Bioscience Ltd12 sites in 1 country150 target enrollmentOctober 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
Efficacy
Status
Terminated
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 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.

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

Investigators

Eligibility Criteria

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%

Outcomes

Primary Outcomes

Efficacy

Time Frame: Study Duration

Secondary Outcomes

  • Safety and Tolerability(Study Duration)

Study Sites (12)

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