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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:
ClinicalTrials.gov Identifier:
NCT00141492
First Posted: September 1, 2005
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: October 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141492


  Show 70 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00141492     History of Changes
Other Study ID Numbers: S176.2.101
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 21, 2015
Last Verified: January 2009

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents