Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome

Uras, Roberto; Orrù, Marisa; Pani, Fabiana; Marotto, Maria Francesca; Pilloni, Monica; Guerriero, Stefano; Etzi, Rossella; Zedda, Pierina; Sorge, Roberto; Lello, Stefano; Melis, Gian Benedetto; Paoletti, Anna Maria

doi:10.1016/j.contraception.2010.01.022

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Volume 82, Issue 2 , Pages 131-138, August 2010

Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome

Roberto Uras
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Marisa Orrù
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Fabiana Pani
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Maria Francesca Marotto
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Monica Pilloni
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Stefano Guerriero
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Rossella Etzi
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Pierina Zedda
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Roberto Sorge
- Laboratory of Biometry, University of Rome “Tor Vergata”, 00133 Roma, Italy
Stefano Lello
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
Gian Benedetto Melis
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy
- Corresponding author. Clinica Ginecologica Ostetrica e di Fisiopatologia della Riproduzione Umana del Dipartimento Chirurgico Materno-Infantile e di Scienze delle Immagini, Università degli Studi di Cagliari, Via Ospedale 46, 09124 Cagliari, Italy. Tel.: +39 070 652797; fax: +39 070 668575.
Anna Maria Paoletti
- Department of Obstetrics and Gynaecology, University of Cagliari, 09124 Cagliari, Italy

Received 21 October 2009; received in revised form 5 January 2010; accepted 27 January 2010. published online 02 March 2010.

Abstract

Background

Chlormadinone acetate (CMA) is a progestin compound similar to progesterone, with antiandrogenic properties. In healthy eumenorrheic women, it was demonstrated that the monophasic estroprogestin formulation containing CMA (2 mg) plus ethinyl estradiol (EE) (30 mcg) (EE30+CMA) is efficacious both in reducing hyperandrogenic symptoms, fat mass and in improving lipoprotein panel, without changes in insulin-glucose metabolism. These metabolic properties are important for women affected by polycystic ovary syndrome (PCOS) in whom there is a predisposition to insulin resistance.

Study Design

We studied whether in young nonobese women with PCOS (15 subjects, EE30+CMA-PCOS group) a six-cycle treatment with EE30+CMA can reduce androgen levels, androgen bioavailability and the score of hirsutism and acne, and modify glucose-insulin metabolism evaluated by the oral glucose tolerance test and the body composition evaluated by bio-impedenziometry. These parameters were evaluated before (first visit) and during the sixth cycle of EE30+CMA (second visit). All the results were compared with those of a matched-age-group of nonobese PCOS women (15 subjects, no OC-PCOS group) evaluated before (first visit) and after six menstrual cycles in which they did not use any drug or oral contraceptive (second visit).

Results

In the EE30+CMA-PCOS group women, androgen levels and bioavailability, hirsutism and acne score were significantly lower at the second than at the first visit, whereas they did not change in no OC-PCOS group. At the second visit, in both groups, glucose-insulin metabolism and body composition parameters were not affected.

Conclusions

A six-cycle treatment with EE30+CMA is efficacious in nonobese PCOS women to improve hyperandrogenic symptoms, without negative interferences both on body composition and on insulin-glucose metabolism.

Keywords: Chlormadinone acetate, Oral Contraceptives, PCOS