Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

January 29, 2009

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00141492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Official Title ^ICMJE

A Double Blind, Randomized, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Androgel, as an Adjunct to Hypoglycemic Therapy, in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

Brief Summary

This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes
Hypogonadism

Intervention ^ICMJE

Drug: Androgel (testosterone gel)

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

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Able to read and write
Males
Between 30-80 years old
Have type 2 diabetes
Diagnoses of hypogonadism or low testosterone

Exclusion Criteria:

On insulin monotherapy
Use of testosterone therapy within the last 6 months
Male breast cancer
History of prostate cancer
History of clinically significant sleep apnea

Gender

Male

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00141492

Responsible Party

Study ID Numbers ^ICMJE

S176.2.101

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

January 2009

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