EUCTR2005-002607-17-DE
Active, not recruiting
Not Applicable
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2
Prostrakan Pharmaceuticals Ltd0 sites520 target enrollmentAugust 16, 2005
DrugsTostrex 2% Gel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failure
- Sponsor
- Prostrakan Pharmaceuticals Ltd
- Enrollment
- 520
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male patients aged at least 40 years old
- •2\. An early morning total testosterone level less than or equal to 11 nmol/L or calculated free testosterone levels less than or equal to 255 pmol/L, at least two separate timepoints, (between 08\.00 \- 10\.00\), at least one week apart.
- •3\. At least two symptoms of hypogonadism (e.g. decreased libido, erectile function, lean body mass or muscle mass; decrease in bone mineral density resulting in osteoporosis; depression, irritability and diminution of mental acuity; fatigue; and vasomotor symptoms, such as hot flushes)
- •4\. Metabolic syndrome as defined by the International Diabetes Federation (IDF):
- •Central obesity (defined as a waist circumference greater than or equal to 94 cm for Europid men, with ethnicity specific values for other groups) and any two of the following four factors:
- •(a) raised TG level: greater or equal to 150 mg/dL (greater or equal to 1\.7 mmol/L), or specific treatment for this lipid abnormality
- •(b) reduced HDL cholesterol: less than 40 mmol/L (less then 1\.03mmol/L) in males, or specific treatment for this lipid abnormality
- •(c) raised blood pressure: systolic BP greater than or equal to 130 mmHg or diastolic BP greater than or equal to 85 mmHg, or treatment of previously diagnosed hypertension
- •(d) raised fasting plasma glucose (FPG) greater than or equal to 100 mg/dL (greater than or equal to 5\.6 mmol/L), or previously diagnosed type 2 diabetes mellitus. If above 100 mg/dL or 5\.6 mmol/L, an oral glucose tolerance test (OGTT) is strongly recommended but is not necessary to define presence of the syndrome.
- •and/or type 2 diabetes mellitus as defined by:
Exclusion Criteria
- •1\. Treatment with testosterone replacement therapy within 6 months of randomisation
- •2\. Use of any other hormone manipulating therapy, or glucocorticoids and topical steroids (intranasal, inhaled or dermal) within 3 months of randomisation
- •3\. Insulin treated patients
- •4\. History of, or current prostate carcinoma
- •5\. Age\-adjusted elevated PSA level
- •6\. Abnormal DRE of prostate, suggestive of cancer
- •7\. Severe symptomatic benign prostatic hyperplasia
- •8\. Patients actively or potentially trying to start a family or requiring fertility treatment
- •9\. Clinically significant hepatic, respiratory, haematological (haematocrit more than 52% at Screening) or renal disease
- •10\. History of drug or alcohol abuse
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes MellitusEUCTR2005-002607-17-ITSTRAKAN PHARMACEUTICALS LIMITED320
Active, not recruiting
Phase 1
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failureEUCTR2005-002607-17-GBProstrakan Pharmaceuticals Ltd520
Active, not recruiting
Not Applicable
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2EUCTR2005-002607-17-BEProStrakan Ltd520
Active, not recruiting
Phase 1
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes MellitusEfecto de la terapia sustitutiva de testosterona transdérmica en hombres hipogonadales o con síndrome metabólico o con diabetes mellitus tipo 2 - TIMES 2Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failureEUCTR2005-002607-17-ESStrakan Pharmaceuticals Ltd530
Active, not recruiting
Not Applicable
Effect of Transdermal Testosterone Replacement in Hypogonadal Men with either Metabolic Syndrome or Type 2 Diabetes Mellitus - TIMES 2Male hypogonadism is generally characterised by abnormally low serum testosterone levels. Symptoms include changes in mood, decreased bone mineral density, increased body fat, decreased muscle mass and strength and sexual dysfunction. A number of conditions can also be associated with decreased testosterone production including metabolic syndrome, type II diabetes mellitus, atherosclerosis, myocardial infarction and chronic heart failureEUCTR2005-002607-17-SEProstrakan Pharmaceuticals Ltd520