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

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.

Evidence that in healthy young women, a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol plus 2 mg of chlormadinone acetate reduces fat mass.

BACKGROUND: We aimed to evaluate whether a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol (EE2) plus 2 mg of chlormadinone acetate (CMA) (EE2+CMA) alters body weight (BW) and body composition of healthy young women with normal menstrual cycles. The results in treated subjects were compared to those obtained in nontreated women as control. STUDY DESIGN: Multifrequency bioelectrical impedance analysis (MF-BIA) was performed in 48 healthy young women during the follicular phase of their menstrual cycle. Of this group, 24 women were treated with EE2+CMA, and the MF-BIA was repeated at the third and sixth cycle of treatment. The remaining 24 women were submitted to the same examinations after three and six cycles without any treatment. Total body water (TBW), intracellular water (ICW), extracellular water (ECW), fat mass (FM) and fat-free mass (FFM) were calculated. Waist-to-hip ratio (WHR), BW, blood pressure, and the plasma concentrations of electrolytes were also measured at each visit. RESULTS: Mean FM significantly (p<.05) decreased in the EE2+CMA group from basal levels of 14.23+/-1.03 to 13.51+/-1.09 and 12.71+/-1.02 kg at the third and sixth cycle of treatment, respectively. Stable values were seen in the control group. During observation, other parameters (BW, WHR, TBW, ECW, ICW, FFM) remained unchanged in all subjects. CONCLUSIONS: EE2+CMA reduces FM without altering TBW, ICW, ECW. These preliminary results suggest that progestational activity of CMA could balance both fluid retention and weight gain elicited by EE2.