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In this first prospective, double-blind, randomized, parallel-group study we evaluated the influence of two combined oral contraceptives on bone mineral density (BMD) and metabolic bone parameters. One dose-reduced preparation contained 20 μg ethinylestradiol (EE) in combination with 100 μg levonorgestrel (LNG) (20/100) was compared with the reference preparation which contained 30 μg EE in combination with 150 μg LNG (30/150). Data from 48 volunteers aged 20–35 years were obtained over an observation period of 36 treatment cycles. The direction of the change (increase or decrease) in all investigated bone-related variables was similar in both treatment groups. As compared to baseline, bone mineral density decreased by 0.4% in the 20/100 group and by 0.8% in the 30/150 group after 36 treatment cycles. These changes were not significantly different between the two treatment groups (p = 0.902). For bone-specific alkaline phosphatase, we measured a mean increase of 55.4% (20/100 group) and of 113.2% (30/150 group) after 36 treatment cycles. The two treatments did not differ statistically significantly (p = 0.522). With respect to cross-linked N-telopeptides (NTx), we detected a decrease of the mean NTx urine concentrations of 21.1% (20/100) and of 13.4% (30/150). These changes also did not significantly differ between the two treatments (p = 0.613). Both study treatments were safe and well-tolerated by all volunteers participating in the study. In conclusion, BMD did not change during the 3-year observation period. Thus, both trial preparations containing either 20 or 30 μg EE in combination with LNG were capable of maintaining BMD in young fertile women. There is no reason to assume that the EE dose reduction had any negative impact on BMD. Because there were no differences in BMD between the treatment groups, it can be assumed that even lower dosages than 20 μg EE might be sufficient for bone protection. Biochemical markers provided evidence for a reduced bone resorption. [Copyright &y& Elsevier]

In this open label, randomized study we compared the influence of a dose-reduced oral contraceptive containing 20 μg ethinyl estradiol (EE) and 100 μg levonorgestrel (20 EE) with a reference preparation containing 30 μg EE and 150 μg levonorgestrel (30 EE) on hemostatic, lipids, and carbohydrate metabolism variables.Data from 48 volunteers were obtained. The direction of the change (increase or decrease) in most of the hemostatic variables were similar in both treatment groups. In particular, prothrombin fragment 1 + 2 increased during treatment, reaching a median percent change of 40% in the 20 EE group and of 17% in the 30 EE group after one year. D-Dimer fibrin split products remained virtually unchanged, with no change at Cycle 13.The median HDL2 cholesterol levels decreased by 26% in the 20 EE group and by 39.8% in 30 EE group (p = 0.0045 for group difference) after one year. The median one year change for LDL cholesterol was 3.23% in the 20 EE group, compared to 25% in the 30 EE group, for VLDL 11.1% compared to 38.8%, respectively, and for total triglycerides 10.0% compared to 37.5%, respectively.The median absolute change for the area under the curve (AUC)(0–3h) for glucose at treatment Cycle 13 was 41.25 mmol/L × min in the 20 EE group and 73.50 mmol/L × min in the 30 EE group. The AUC(0–3h) insulin at treatment Cycle 13 decreased in the 20 EE group by 1635.0 pmolL × min and increased in the 30 EE group by 11797.5 pmolL × min (p = 0.0491 for group difference). Both study treatments were safe and well tolerated by the volunteers.In conclusion, the balanced one-third dose reduction in this new oral contraceptive evoked similar effects on the hemostatic variables, but favorable results for the lipid and carbohydrate profiles. [Copyright &y& Elsevier]