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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597051
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
Information provided by:
Ardana Bioscience Ltd

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: ARD-0403 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : October 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pharmacokinetic

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00597051     History of Changes
Other Study ID Numbers: ARD-0403-001
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents