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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00597051
Acronym
ARD-0403-001
Enrollment
42
Registered
2008-01-17
Start date
2005-10-31
Completion date
2006-02-28
Last updated
2008-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

Brief summary

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

Interventions

DRUGARD-0403

Sponsors

Ardana Bioscience Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
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%

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic—

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026