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

This study has been completed.
Sponsor:
Information provided by:
Ardana Bioscience Ltd
ClinicalTrials.gov Identifier:
NCT00597051
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: January 2008
  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
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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014