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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141492
First received: August 30, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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 2

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

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:

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

Exclusion Criteria:

  1. On insulin monotherapy
  2. Use of testosterone therapy within the last 6 months
  3. Male breast cancer
  4. History of prostate cancer
  5. 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

ClinicalTrials.gov Identifier: NCT00141492     History of Changes
Other Study ID Numbers: S176.2.101
Study First Received: August 30, 2005
Last Updated: January 29, 2009
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
 Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 16, 2013