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Drospirenone for the Treatment of Hirsute Women with Polycystic Ovary Syndrome: A Clinical, Endocrinological, Metabolic Pilot Study

Department of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore (M.Gu., D.R., M.Gi., R.S., L.S., R.A., A.L.), 00168 Rome, Italy; and OASI Institute for Researche (A.L.), 94018 Troina, Italy

Address all correspondence and requests for reprints to: Dr. M. Guido, Department of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168 Rome, Italy. E-mail: m.guido{at}rm.unicatt.it.

The aim of this study was to investigate the effects of the new estro-progestinic containing the antimineralcorticoid progestogen drospirenone (DRSP) in women with polycystic ovary syndrome (PCOS). Fifteen hirsute PCOS patients were treated with 30 µg ethinyl estradiol plus 3 mg DRSP for 12 cycles. Ultrasonographic pelvic exams, evaluation of hirsutism scores, and hormonal and lipid profile assays were performed at baseline and after three, six, and 12 cycles of treatment. An oral glucose tolerance test and euglycemic hyperinsulinemic clamp were also performed, except at the third cycle. The treatment was well tolerated, and all women attained satisfactory cycle control. Hirsutism significantly improved from the sixth cycle onward. Body weight and fat distribution as well as blood pressure remained stable throughout the treatment. Plasma levels of LH, testosterone, SHBG, and, consequently, the free androgen index significantly fell from the third cycle on. Dehydroepiandrosterone sulfate and 17-hydroxyprogesterone significantly decreased after six cycles. The treatment did not affect glycoinsulinemic homeostasis. A trend toward an increase was seen for total cholesterol, triglycerides, and high- and low-density lipoproteins (HDL and LDL) plasma concentrations, although all parameters remained within the normal range. No modifications in total cholesterol/HDL and HDL/LDL ratios were induced by the therapy. The ethinyl estradiol/DRSP combination seems to be effective in ameliorating clinical and hormonal features of PCOS.

Abbreviations: CPA, Cyproterone acetate; DRSP, drospirenone; EE, ethinyl estradiol; FAI, free androgen index; F-G, Ferriman-Gallwey; HDL, high-density lipoprotein; LDL, low-density lipoprotein; NEFA, nonesterified fatty acid; OGTT, oral glucose tolerance test; PCOS, polycystic ovary syndrome; VLDL, very LDL.

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