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

NCT ID: NCT00597051

Last Updated: 2008-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-02-28

Brief Summary

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

Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ARD-0403

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ardana Bioscience Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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Tatiana Mokhort, MD

Role: PRINCIPAL_INVESTIGATOR

Republican Endocrinology Center Hospital, Minsk, Republic of Belarus

Locations

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Republican Endocrinology Center Hospital

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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ARD-0403-001

Identifier Type: -

Identifier Source: org_study_id

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