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The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 1 139-146
Copyright © 2000 by The Endocrine Society

Original Studies

Metformin Effects on Clinical Features, Endocrine and Metabolic Profiles, and Insulin Sensitivity in Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled 6-Month Trial, followed by Open, Long-Term Clinical Evaluation1

Paolo Moghetti, Roberto Castello, Carlo Negri, Flavia Tosi, Fabrizia Perrone, Marco Caputo, Elisabetta Zanolin and Michele Muggeo

Division of Endocrinology and Metabolic Diseases (P.M., R.C., C.N., F.T., F.P., M.M.), and Division of Medical Statistics (E.Z.), University of Verona, Verona; Laboratory of Clinical Chemistry (M.C.), Ospedale Maggiore, Verona, Italy

Address correspondence and requests for reprints to: Dr. Paolo Moghetti, Divisione di Endocrinologia e Malattie del Metabolismo, Ospedale Maggiore, P.le Stefani, 1 I-37126 Verona, Italy. E-mail: moghetti{at}iol.it

In the last few years some studies assessed the effects of attenuation of hyperinsulinemia and insulin resistance, obtained by insulin sensitizing agents, in women with polycystic ovary syndrome (PCOS), suggesting potential scope for these drugs in treating the whole spectrum of reproductive, endocrine, and metabolic abnormalities found in such subjects. However, the results of these studies, mostly uncontrolled and short-term, are still inconclusive, and there is no long-term follow-up. In the present study, 23 PCOS subjects [mean (± SE) body mass index 30.0 ± 1.1 kg/m2] were randomly assigned to double-blind treatment with metformin (500 mg tid) or placebo for 6 months, while maintaining their usual eating habits. Before and after treatment, menstrual history, endocrine and metabolic profiles, serum 17-hydroxyprogesterone response to GnRH-agonist testing, and insulin sensitivity measured by the glucose clamp technique were assessed. Eighteen of these women, as well as 14 additional PCOS patients, were subsequently given metformin in an open trial for 11.0 ± 1.3 months (range 4–26), to assess long-term effects of treatment and baseline predictors of metformin efficacy on reproductive abnormalities. After metformin treatment, mean frequency of menstruation improved (P = 0.002), due to striking amelioration of menstrual abnormalities in about 50% of subjects. Women given metformin showed reduced plasma insulin (at fasting: P = 0.057; during the clamp studies: P < 0.01) and increased insulin sensitivity (P < 0.05). Concurrently, ovarian hyperandrogenism was attenuated, as indicated by significant reductions in serum free testosterone (P < 0.05) and in the 17-hydroxyprogesterone response to GnRH-agonist testing (P < 0.05). No changes were found in the placebo group. Only comparable minor changes in body mass index were found both in the metformin group and in the placebo group. In the open, long-term trial 17 women (54.8%) showed striking improvements of their menstrual abnormalities and were considered as responders. Logistic regression analysis of baseline characteristics in responders and nonresponders showed that plasma insulin, serum androstenedione, and menstrual history were independent predictors of the treatment’s clinical efficacy. In 10 subjects whose menses proved regular after treatment, the great majority of cycles became ovulatory (32 out of 39 assessed, 79%). In conclusion, in women with PCOS metformin treatment reduced hyperinsulinemia and hyperandrogenemia, independently of changes in body weight. In a large number of subjects these changes were associated with striking, sustained improvements in menstrual abnormalities and resumption of ovulation. Higher plasma insulin, lower serum androstenedione, and less severe menstrual abnormalities are baseline predictors of clinical response to metformin.




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S. S. George, K. George, C. Irwin, V. Job, R. Selvakumar, V. Jeyaseelan, and M.S. Seshadri
Sequential treatment of metformin and clomiphene citrate in clomiphene-resistant women with polycystic ovary syndrome: a randomized, controlled trial
Hum. Reprod., February 1, 2003; 18(2): 299 - 304.
[Abstract] [Full Text] [PDF]

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L. Morin-Papunen, I. Vauhkonen, R. Koivunen, A. Ruokonen, H. Martikainen, and J. S. Tapanainen
Metformin Versus Ethinyl Estradiol-Cyproterone Acetate in the Treatment of Nonobese Women with Polycystic Ovary Syndrome: A Randomized Study
J. Clin. Endocrinol. Metab., January 1, 2003; 88(1): 148 - 156.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
L. Ibanez and F. de Zegher
Low-dose combination of flutamide, metformin and an oral contraceptive for non-obese, young women with polycystic ovary syndrome
Hum. Reprod., January 1, 2003; 18(1): 57 - 60.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
L. A. Stadtmauer, B. C. Wong, and S. Oehninger
Should patients with polycystic ovary syndrome be treated with metformin?: Benefits of insulin sensitizing drugs in polycystic ovary syndrome--beyond ovulation induction
Hum. Reprod., December 1, 2002; 17(12): 3016 - 3026.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
C. J. Glueck, P. Wang, N. Goldenberg, and L. Sieve-Smith
Pregnancy outcomes among women with polycystic ovary syndrome treated with metformin
Hum. Reprod., November 1, 2002; 17(11): 2858 - 2864.
[Abstract] [Full Text] [PDF]

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C. Schofl, R. Horn, T. Schill, H. W. Schlosser, M. J. Muller, and G. Brabant
Circulating Ghrelin Levels in Patients with Polycystic Ovary Syndrome
J. Clin. Endocrinol. Metab., October 1, 2002; 87(10): 4607 - 4610.
[Abstract] [Full Text] [PDF]

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R. Murray
Recognizing the Signs of Metabolic Syndrome and Polycystic Ovary Syndrome in a Caucasian Adolescent Girl: Differentiating Type 2 From Type 1 Diabetes
Diabetes Spectr, October 1, 2002; 15(4): 227 - 231.
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 Hum ReprodHome page
E. Seli and A. J. Duleba
Should patients with polycystic ovarian syndrome be treated with metformin?
Hum. Reprod., September 1, 2002; 17(9): 2230 - 2236.
[Abstract] [Full Text] [PDF]

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J. E. Nestler
Should patients with polycystic ovarian syndrome be treated with metformin?: An enthusiastic endorsement
Hum. Reprod., August 1, 2002; 17(8): 1950 - 1953.
[Abstract] [Full Text] [PDF]

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 ANN INTERN MEDHome page
D. Kirpichnikov, S. I. McFarlane, and J. R. Sowers
Metformin: An Update
Ann Intern Med, July 2, 2002; 137(1): 25 - 33.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
K. Elter, G. Imir, and F. Durmusoglu
Clinical, endocrine and metabolic effects of metformin added to ethinyl estradiol-cyproterone acetate in non-obese women with polycystic ovarian syndrome: a randomized controlled study
Hum. Reprod., July 1, 2002; 17(7): 1729 - 1737.
[Abstract] [Full Text] [PDF]

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L. Ibanez, C. Valls, A. Ferrer, K. Ong, D. B. Dunger, and F. de Zegher
Additive Effects of Insulin-Sensitizing and Anti-Androgen Treatment in Young, Nonobese Women with Hyperinsulinism, Hyperandrogenism, Dyslipidemia, and Anovulation
J. Clin. Endocrinol. Metab., June 1, 2002; 87(6): 2870 - 2874.
[Abstract] [Full Text] [PDF]

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 Diabetes CareHome page
Z. T. Bloomgarden
Neuropathy, Womens' Health, and Socioeconomic Aspects of Diabetes
Diabetes Care, June 1, 2002; 25(6): 1085 - 1094.
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V. Jayagopal, E. S. Kilpatrick, S. Holding, P. E. Jennings, and S. L. Atkin
The Biological Variation of Insulin Resistance in Polycystic Ovarian Syndrome
J. Clin. Endocrinol. Metab., April 1, 2002; 87(4): 1560 - 1562.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
R. Homburg
Should patients with polycystic ovarian syndrome be treated with metformin?: A note of cautious optimism
Hum. Reprod., April 1, 2002; 17(4): 853 - 856.
[Abstract] [Full Text] [PDF]

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D. J. Jakubowicz, M. J. Iuorno, S. Jakubowicz, K. A. Roberts, and J. E. Nestler
Effects of Metformin on Early Pregnancy Loss in the Polycystic Ovary Syndrome
J. Clin. Endocrinol. Metab., February 1, 2002; 87(2): 524 - 529.
[Abstract] [Full Text] [PDF]

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R. Fleming, Z. E. Hopkinson, A. M. Wallace, I. A. Greer, and N. Sattar
Ovarian Function and Metabolic Factors in Women with Oligomenorrhea Treated with Metformin in a Randomized Double Blind Placebo-Controlled Trial
J. Clin. Endocrinol. Metab., February 1, 2002; 87(2): 569 - 574.
[Abstract] [Full Text] [PDF]

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H. Yarali, B. O. Yildiz, A. Demirol, H. B. Zeyneloglu, N. Yigit, O. Bukulmez, and Z. Koray
Co-administration of metformin during rFSH treatment in patients with clomiphene citrate-resistant polycystic ovarian syndrome: a prospective randomized trial
Hum. Reprod., February 1, 2002; 17(2): 289 - 294.
[Abstract] [Full Text] [PDF]

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E. H. Y. Ng, N. M. S. Wat, and P. C. Ho
Effects of metformin on ovulation rate, hormonal and metabolic profiles in women with clomiphene-resistant polycystic ovaries: a randomized, double-blinded placebo-controlled trial
Hum. Reprod., August 1, 2001; 16(8): 1625 - 1631.
[Abstract] [Full Text] [PDF]

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 Diabetes CareHome page
H. R. Peppard, J. Marfori, M. J. Iuorno, and J. E. Nestler
Prevalence of Polycystic Ovary Syndrome Among Premenopausal Women With Type 2 Diabetes
Diabetes Care, June 1, 2001; 24(6): 1050 - 1052.
[Abstract] [Full Text]

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R. Azziz, D. Ehrmann, R. S. Legro, R. W. Whitcomb, R. Hanley, A. G. Fereshetian, M. O’Keefe, and M. N. Ghazzi
Troglitazone Improves Ovulation and Hirsutism in the Polycystic Ovary Syndrome: A Multicenter, Double Blind, Placebo-Controlled Trial
J. Clin. Endocrinol. Metab., April 1, 2001; 86(4): 1626 - 1632.
[Abstract] [Full Text]

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 J. Clin. Endocrinol. Metab.Home page
D. J. Jakubowicz, M. Seppälä, S. Jakubowicz, O. Rodriguez-Armas, A. Rivas-Santiago, H. Koistinen, R. Koistinen, and J. E. Nestler
Insulin Reduction with Metformin Increases Luteal Phase Serum Glycodelin and Insulin-Like Growth Factor-Binding Protein 1 Concentrations and Enhances Uterine Vascularity and Blood Flow in the Polycystic Ovary Syndrome
J. Clin. Endocrinol. Metab., March 1, 2001; 86(3): 1126 - 1133.
[Abstract] [Full Text]

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 J. Clin. Endocrinol. Metab.Home page
J. E. Nestler
Metformin and the Polycystic Ovary Syndrome
J. Clin. Endocrinol. Metab., March 1, 2001; 86(3): 1430 - 1430.
[Full Text]

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 DTBHome page
Tackling polycystic ovary syndrome
DTB, January 1, 2001; 39(1): 1 - 5.
[Abstract] [Full Text] [PDF]

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S. E. Oberfield
Metabolic Lessons from the Study of Young Adolescents with Polycystic Ovary Syndrome--Is Insulin, Indeed, the Culprit?
J. Clin. Endocrinol. Metab., October 1, 2000; 85(10): 3520 - 3525.
[Full Text]

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L. Ibáñez, C. Valls, N. Potau, M. V. Marcos, and F. de Zegher
Sensitization to Insulin in Adolescent Girls to Normalize Hirsutism, Hyperandrogenism, Oligomenorrhea, Dyslipidemia, and Hyperinsulinism after Precocious Pubarche
J. Clin. Endocrinol. Metab., October 1, 2000; 85(10): 3526 - 3530.
[Abstract] [Full Text]

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 J. Clin. Endocrinol. Metab.Home page
L. C. Morin-Papunen, I. Vauhkonen, R. M. Koivunen, A. Ruokonen, H. K. Martikainen, and J. S. Tapanainen
Endocrine and Metabolic Effects of Metformin Versus Ethinyl Estradiol-Cyproterone Acetate in Obese Women with Polycystic Ovary Syndrome: A Randomized Study
J. Clin. Endocrinol. Metab., September 1, 2000; 85(9): 3161 - 3168.
[Abstract] [Full Text]

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R. Pasquali, A. Gambineri, D. Biscotti, V. Vicennati, L. Gagliardi, D. Colitta, S. Fiorini, G. E. Cognigni, M. Filicori, and A. M. Morselli-Labate
Effect of Long-Term Treatment with Metformin Added to Hypocaloric Diet on Body Composition, Fat Distribution, and Androgen and Insulin Levels in Abdominally Obese Women with and without the Polycystic Ovary Syndrome
J. Clin. Endocrinol. Metab., August 1, 2000; 85(8): 2767 - 2774.
[Abstract] [Full Text]


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