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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597051
First Posted: January 17, 2008
Last Update Posted: January 17, 2008
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.
Information provided by:
Ardana Bioscience Ltd
  Purpose
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
Hypogonadism Drug: ARD-0403 Phase 2

Study Type: Interventional
Study Design: 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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00597051


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

ClinicalTrials.gov Identifier: NCT00597051     History of Changes
Other Study ID Numbers: ARD-0403-001
First Submitted: January 8, 2008
First Posted: January 17, 2008
Last Update Posted: January 17, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents