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| Sponsor: | Karolinska Institutet |
|---|---|
| Collaborators: |
Karolinska University Hospital Southern Hospital Stockholm UroHealth Skövde Universitätsklinikum MünsterInstitut für Reproduktionsmedizin Krankenanstalt der Stadt Wien Rudolfstiftung Medical University of Graz Krankenhaus der Stadt Wien Lainz Medizinische Universität Wien Endokrinologikum Hamburg Charite University, Berlin, Germany |
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00479609 |
Purpose
Men with metabolic syndrome often have lower than normal testosterone levels and low testosterone levels have been suggested to predispose for development of type2 diabetes. The aim of the study is to evaluate if normalisation of serum testosterone levels in men with metabolic syndrome (Abdominal obesity, hypertension, dyslipidemia, insulin resistance and pre-diabetes or overt type diabetes)improves sensitivity to insulin and improves the signs of the metabolic syndrome
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: Transdermal testosterone therapy Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Placebo Controlled Study of Transdermal Testosterone Therapy to Investigate the Efficacy and Safety in Men With Abdominal Obesity, Low Testosterone Levels and Early Stages of the Metabolic Cluster Syndrome. |
| Estimated Enrollment: | 176 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo gel
|
Drug: Placebo
Placebo gel
|
|
Active Comparator: 2
Transdermal testostrone therapy
|
Drug: Transdermal testosterone therapy
testosterone 1% hydroalcohol gel
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Metabolic syndrome defined according to the International Diabetes Foundation (IDF):
Exclusion Criteria:
Contacts and Locations| Contact: Stefan Arver, MD, PhD | +46858586876 | stefan.arver@ki.se |
| Contact: Elin Zamore, RN | +46858580466 | Elin.zamore@karolinska.se |
| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, SE14186 | |
| Sub-Investigator: Åke Pousette, MD, PhD | |
| Principal Investigator: | Urban Ekström, MD | Karolinska University Hospital |
More Information
| Responsible Party: | Stefan Arver Associate Prof, Sr Physician, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00479609 History of Changes |
| Other Study ID Numbers: | ARTinMMS |
| Study First Received: | May 25, 2007 |
| Last Updated: | May 6, 2008 |
| Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission |
|
Insulin resistance Glucose tolerance Type 2 diabetes Androgen sensitivity |
|
Diabetes Mellitus, Type 2 Metabolic Syndrome X Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Resistance Hyperinsulinism Testosterone Testosterone enanthate Testosterone undecanoate |
Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |