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

S

Solvay

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes
Hypogonadism

Treatments

Drug: Androgel (testosterone gel)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141492
S176.2.101

Details and patient eligibility

About

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.

Sex

Male

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

70

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Data sourced from clinicaltrials.gov

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