Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00597051
NCT00597051CompletedPhase 2

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Centre Study of the Pharmacokinetics and Tolerability of 3 Different Doses of ARD-0403 in Testosterone Deficient Men

Ardana Bioscience Ltd2 sites in 1 country42 target enrollmentStarted: October 1, 2005Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Pharmacokinetic
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Testosterone deficiency
  • •Normal BMI

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

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 3
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and EnergyHypogonadism
NCT01816295Eli Lilly and Company715
Completed
Phase 3
Study of Transdermal Testosterone Patches in Menopausal Women With Low LibidoHypoactive Sexual Desire Disorder
NCT00131495Warner Chilcott814
Unknown
Phase 3
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal MenMetabolic SyndromeHypogonadism
NCT00696748Russian Academy of Medical Sciences250
Completed
Phase 2
A Study of Ejaculatory Dysfunction in Men With Low Testosterone LevelsHypogonadismEjaculatory Dysfunction
NCT01419236Eli Lilly and Company76
Completed
Phase 3
Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)Androgens (Deficiency)Male
NCT00185198Bayer363
Study of 3 Doses of ARD-0403 in... | Clinical Trial