drugset / Trial / NCT00479609
Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes
Phase 3
Unknown
176 enrolled
Karolinska Institutet
Charite University, Berlin, Germany · collabEndokrinologikum Hamburg · collabKarolinska University Hospital · collabKrankenanstalt der Stadt Wien Rudolfstiftung · collabKrankenhaus der Stadt Wien Lainz · collabMedical University of Graz · collabMedical University of Vienna · collabSouthern Hospital Stockholm · collabUniversitätsklinikum MünsterInstitut für Reproduktionsmedizin · collabUroHealth Skövde · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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
Timeline
- Start
- 2007-04
- Primary completion
- 2009-01
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Testosterone | Small molecule | 75 mg | Other |