A randomised placebo controlled study of transdermal testosterone therapy (testosterone 1% hydroalcohol gel) to investigate the efficacy and safety in men with abdominal obesity, low testosterone levels and early stages of the metabolic cluster syndrome. - ARTinMMS
- Conditions
- The metabolic syndrome constitutes a cluster of risk factors for cardiovascular disease with increased morbidity and mortality. The metabolic syndrome is referred to as a concomitant occurrence of hypertension, hyperlipidemia, impaired glucose tolerance with insulin resistance and abdominal obesity. .MedDRA version: 8.1Level: LLTClassification code 10052066Term: Metabolic syndrome
- Registration Number
- EUCTR2006-003101-53-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 176
1. Male 30 to 70 years (inclusive)
2. Metabolic syndrome defined according to the International Diabetes Foundation
(IDF):
a) Abdominal obesity (waist circumference > 94 cm for European men) and any two of the following criteria
b) Triglycerides > 1.7 mmol/L or specific treatment for this
c) HDL < 1.03 nmol/L or specific therapy for this
d) Systolic blood pressure = 130 mmHg or diastolic BP = 85 mmHg or treatment for this
e) Fasting plasma glucose = 5.6 mmol/L
or previously diagnosed type 2 diabetes mellitus defined by:
Fasting plasma glucose = 7.8 mmol/L on two occasions, or random glucose = 11.1 mmol/L and classic symptoms of type 2 diabetes
3.Impaired glucose tolerance
If the definition of the metabolic syndrome, as described above, is fulfilled but fasting plasma glucose < 5.6 mmol/L the result of an oral glucose tolerance test must be classified as reduced glucose tolerance with a venous blood glucose 7.8 - 11.1 mmol/L or higher 120 min after intake of 75 g of glucose in a water solution (2h OGTT) (www.diabetes.org/main/info/pre-diabetes.jsp)
4.Hypogonadism, S-Testosterone <= 12 nmol/L taken at 8:00-10:00 a.m. and less than 2 months before inclusion in the study.
5.Screening value of HbA1c <8.0 %
6.Weight below and inclusive 120 kg
7.Body Mass Index (BMI) below and inclusive 40
8.Hematocrit below and inclusive 50%
9.Signed Written informed consent obtained
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
1.Insulin therapy and therapy with glitazones.
2.Use of androgen therapy or anabolic steroids within 6 months of entry into the study.
3.Known congestive heart failure, progressing angina pectoris or a history of myocardial infarction within the last 12 months.
4.Known untreated pituitary disease.
5.A history of significant renal or liver disease or any malignancy.
6.Any disease requiring long-term use of drugs interfering with androgens; spironolactone, Ketoconazol, corticosteroids, cimetidin, fentiazines, tricyclic antidepressives, anabolic steroids, 5-alfa reductase inhibitors, antiestrogens.
7.Prostate Specific Antigen (PSA) >= 4 ng/ml.
8.Suspected malignancy after prostata palpation, unless biopsy shows the opposite.
9.Malignant tumour of the mammary gland
10.Ongoing micturition problem severely affecting patient’s daily living at the discretion of the investigators judged by the investigator.
11.Any contraindication for treatment with testosterone 1% hydroalchol gel according to the labelling as well as known or suspected allergy to the specific product used in the study.
12.Contagious blood disease.
13.Known alcohol or drug abuse, or any condition associated with poor compliance.
14.Participation in a clinical study during the last 90 days before start of treatment.
15.Previous enrolment or randomisation in the present study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method