Exenatide and Metformin Therapy in Overweight Women With PCOS
Completed · Phase 2
Conditions studied: Polycystic Ovary Syndrome
In brief
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.
Key facts
- Study ID
- NCT00344851
- Run by
- Metabolic Center of Louisiana Research Foundation
- People needed
- 60
- Starts
- 2006-06-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2007-07-11
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia or presence of overt diabetes alterations in hepatic or renal function use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks Known active substance abuse including tobacco and alcohol. Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months
Where it is running
- Facility: Metabolic Center of Louisiana Research Foundation — Baton Rouge, Louisiana, United States
Full record on ClinicalTrials.gov
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