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

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
ARD-0403
Sponsored by
Ardana Bioscience Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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%

Sites / Locations

  • Republican Endocrinology Center Hospital

Outcomes

Primary Outcome Measures

Pharmacokinetic

Secondary Outcome Measures

Full Information

First Posted
January 8, 2008
Last Updated
January 16, 2008
Sponsor
Ardana Bioscience Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00597051
Brief Title
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
Acronym
ARD-0403-001
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ardana Bioscience Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ARD-0403
Primary Outcome Measure Information:
Title
Pharmacokinetic

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Mokhort, MD
Organizational Affiliation
Republican Endocrinology Center Hospital, Minsk, Republic of Belarus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Republican Endocrinology Center Hospital
City
Minsk
ZIP/Postal Code
220 007
Country
Belarus

12. IPD Sharing Statement

Learn more about this trial

Study of 3 Doses of ARD-0403 in Testosterone Deficient Men

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