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

This study has been completed.

First Received: August 30, 2005 Last Updated: January 29, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00141492

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Hypogonadism	Drug: Androgel (testosterone gel)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

October 2004

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141492

Show 70 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	S176.2.101
Study First Received:	August 30, 2005
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00141492 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Type 2 diabetes
hypogonadism
testosterone
glycosylated hemoglobin A1C

Additional relevant MeSH terms:

Metabolic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Androgens

ClinicalTrials.gov processed this record on February 08, 2010