Study of 3 Doses of ARD-0403 in Testosterone Deficient Men (ARD-0403-001)

This study has been completed.
Information provided by:
Ardana Bioscience Ltd Identifier:
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: January 2008

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

Condition Intervention Phase
Drug: ARD-0403
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ardana Bioscience Ltd:

Primary Outcome Measures:
  • Pharmacokinetic

Enrollment: 42
Study Start Date: October 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   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%
  Contacts and Locations
Please refer to this study by its identifier: NCT00597051

Republican Endocrinology Center Hospital
Minsk, Belarus, 220 007
Sponsors and Collaborators
Ardana Bioscience Ltd
Principal Investigator: Tatiana Mokhort, MD Republican Endocrinology Center Hospital, Minsk, Republic of Belarus
  More Information

No publications provided Identifier: NCT00597051     History of Changes
Other Study ID Numbers: ARD-0403-001
Study First Received: January 8, 2008
Last Updated: January 16, 2008
Health Authority: Belarus: Ministry of Health

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents processed this record on April 16, 2014