Status:
COMPLETED
Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients
Lead Sponsor:
University Magna Graecia
Conditions:
Polycystic Ovary Syndrome
Anovulation
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief Summary
Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate car...
Detailed Description
Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms. Interventions: A six-month course of metformin ...
Eligibility Criteria
Inclusion
- PCOS
Exclusion
- age \<18 or \>35 years
- BMI \>35 kg/m2
- neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00953355
Start Date
January 1 2004
End Date
May 1 2007
Last Update
November 3 2010
Active Locations (1)
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1
"Pugliese" Hospital
Catanzaro, Italy