drugset / Trial / NCT00344851
Exenatide and Metformin Therapy in Overweight Women With PCOS
Phase 2
Completed
60 enrolled
Metabolic Center of Louisiana Research Foundation
Amylin Pharmaceuticals, LLC. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.
Timeline
- Start
- 2006-06
- Primary completion
- —
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 10 ug | — |
| Subject | Metformin | Small molecule | 1000 mg | — |