NCT00597051

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

January 8, 2008

Last Update Submit

January 16, 2008

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic

Interventions

ARD-0403DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Testosterone deficiency
  • Normal BMI

You may not qualify if:

  • Previous treatment with testosterone replacement therapy within 4 weeks
  • Moderate-severe benign prostatic hypertrophy, or prostatic cancer
  • Haematocrit \>50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Republican Endocrinology Center Hospital

Minsk, 220 007, Belarus

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Tatiana Mokhort, MD

    Republican Endocrinology Center Hospital, Minsk, Republic of Belarus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

October 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

BE(1)