NCT00597051
Completed
Phase 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
ConditionsHypogonadism
DrugsARD-0403
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypogonadism
- Sponsor
- Ardana Bioscience Ltd
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic
- Status
- Completed
- Last Updated
- 18 years ago
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.
Investigators
Eligibility Criteria
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
Study Sites (1)
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