Title
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
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
Phase
Phase 2Lead Sponsor
Ardana Bioscience LtdStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HypogonadismIntervention/Treatment
ard-0403 ...Study Participants
42The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.
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%