Status:
COMPLETED
Exenatide and Metformin Therapy in Overweight Women With PCOS
Lead Sponsor:
Metabolic Center of Louisiana Research Foundation
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief 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...
Detailed Description
Objectives: The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with exenatide and metformin alone, to combination therapy in women with PCOS. ...
Eligibility Criteria
Inclusion
- Overweight/obese women (BMI\>27)
- Must have six or fewer menses /year or be amenorrheic
- Have either clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T)) and /or PCOS ovary on ultrasound
Exclusion
- 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
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Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00344851
Start Date
June 1 2006
End Date
June 1 2007
Last Update
July 11 2007
Active Locations (1)
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1
Facility: Metabolic Center of Louisiana Research Foundation
Baton Rouge, Louisiana, United States, 70808