title: Metformin effects on ovarian ultrasound appearance and steroidogenic function in normal-weight normoinsulinemic women with polycystic ovary syndrome: a randomized double-blind placebo-controlled clinical trial.
abstract: OBJECTIVE
  To investigate metformin effects on the endocrine-metabolic parameters and ovarian morphology in normoinsulinemic women with polycystic ovary syndrome (PCOS).
  
  
  METHODS
  Randomized double-blind study.
  
  
  METHODS
  Operative Division of Endocrinological Gynecology, Università Cattolica del Sacro Cuore.
  
  
  METHODS
  Twenty-eight normal-weight normoinsulinemic PCOS women.
  
  
  METHODS
  Patients were randomized to receive metformin 500 mg twice a day (group A, 15 subjects) or placebo (group B, 13 subjects) for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, and oral glucose tolerance test were performed at baseline and after 3 and 6 months of treatment.
  
  
  METHODS
  Hormonal and glycoinsulinemic assessment, ovarian ultrasound appearance.
  
  
  RESULTS
  Glycoinsulinemic assessment remained unvaried in both groups. About 70% of patients in group A experienced a restoration of menstrual cyclicity. Metformin significantly decreased testosterone levels at 3 and 6 months) and 17-hydroxyprogesterone levels at 6 months, and improved hirsutism score at 6 months. No clinical or hormonal modifications occurred in group B. Metformin, but not placebo, reduced ovarian volume and stromal/total area ratio at 3 and 6 months.
  
  
  CONCLUSIONS
  Metformin seems to improve the menstrual pattern and ultrasonographic ovarian features in normoinsulinemic PCOS women. These effects seem to be, at least in part, independent of the insulin-lowering properties of the drug.
authors.affiliation: Department of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Romualdi
authors.forename: Maddalena
authors.initials: M
authors.lastname: Giuliani
authors.forename: Francesca
authors.initials: F
authors.lastname: Cristello
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Fulghesu
authors.forename: Luigi
authors.initials: L
authors.lastname: Selvaggi
authors.forename: Antonio
authors.initials: A
authors.lastname: Lanzone
authors.forename: Maurizio
authors.initials: M
authors.lastname: Guido
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D012739:Gonadal Steroid Hormones / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000494:pharmacology; D056865:Ideal Body Weight / Q000502:physiology; D007328:Insulin / Q000097:blood / Q000592:standards; D008687:Metformin / Q000008:administration & dosage / Q000494:pharmacology*; D010053:Ovary / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000378:metabolism / Q000502:physiology*; D010919:Placebos; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000000981:diagnostic imaging* / Q000378:metabolism / Q000503:physiopathology; D013997:Time Factors; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D012739:Gonadal Steroid Hormones; D007004:Hypoglycemic Agents; D007328:Insulin; D010919:Placebos; D008687:Metformin