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.
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.
Romualdi
Daniela
D
Department of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
Giuliani
Maddalena
M
Cristello
Francesca
F
Fulghesu
Anna Maria
AM
Selvaggi
Luigi
L
Lanzone
Antonio
A
Guido
Maurizio
M
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
D012739:Gonadal Steroid Hormones; D007004:Hypoglycemic Agents; D007328:Insulin; D010919:Placebos; D008687:Metformin