Status:
COMPLETED
Metformin Suspension and Insulin Sensitivity
Lead Sponsor:
University Magna Graecia
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-30 years
Phase:
PHASE4
Brief Summary
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the long-term metformin admin...
Detailed Description
Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS will be based on the presence of clinical \[Ferriman-Gallwey score ≥ 8\] or biochemical hyperandrogenism (seru...
Eligibility Criteria
Inclusion
- Polycystic ovary syndrome (using NIH criteria).
Exclusion
- Age \<20 or \>30 years;
- BMI higher than 25 and lower than 18;
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses;
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia;
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs;
- Intention to start a diet or a specific program of physical activity.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00437333
Start Date
December 1 2003
End Date
April 1 2006
Last Update
February 21 2007
Active Locations (1)
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1
"Pugliese" Hospital
Catanzaro, Italy, 88100