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 2

Phase 1

• 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

• Registration Number: EUCTR2005-002607-17-ES
• Lead Sponsor: Strakan Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-06
• Study Completion: 2008-06-20
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 530

Inclusion Criteria

1. Male patients aged at least 40 years old
2. Two early morning (between 08:00 10:00) total testosterone levels less than 11 nmol/L or calculated free testosterone levels less than 255 pmol/L, 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 Foundation (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 than or equal to 8.33 mmol/L, or specific treatment for this lipid abnormality
(b) reduced HDL cholesterol: less than 2.22 mmol/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 5.6 mmol/L, or previously diagnosed type 2 diabetes mellitus. If above 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:
fasting plasma glucose (FPG) greater than or equal to 7.0 mmol/L on two occasions or random glucose greater than or equal to 11.1 mmol/L and classic symptoms of type 2 diabetes mellitus (polyuria, polydipsia, polyphagia, with / without weight loss).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 Baseline) or renal disease
10. History of drug or alcohol abuse
11. Receiving other trial drugs within 12 weeks
12. Symptomatic obstructive sleep apnoea syndrome
13. History or presence of male breast cancer
14. Hyperprolactinaemia or pituitary tumour
15. Any other reason, which the Investigator feels precludes safe inclusion of the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified