Testosterone Treatment for Hypogonadal Men - Tabular View

Tracking Information

First Received Date ^ICMJE

February 8, 2007

Last Updated Date

November 29, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Percentage of subjects with TT within the normal range

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00433199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate safety for up to one year of use, TNF-alpha, IL-6, IL-10, hs-CRP, MMP-9, HDL2, HDL3, VCAM, D-Dimer, Fibrinogen, Bone-specific alkaline phosphatase, Type 1 cross-linked C telopeptide, SF-36 and % free PSA

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Testosterone Treatment for Hypogonadal Men

Official Title ^ICMJE

A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men

Brief Summary

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Hypogonadism

Intervention ^ICMJE

Drug: Testosterone Gel 1.62%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

224

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Low T males 18 - 80 years of age

Exclusion Criteria:

Normal T levels
Elevated PSA

Gender

Male

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00433199

Responsible Party

Study ID Numbers ^ICMJE

S176.3.104

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP