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Objective: The effects of estetrol (E4), a natural fetal estrogen, combined with drospirenone (DRSP) were evaluated on plasma levels of sex hormone-binding globulin (SHBG), angiotensinogen and 12 hemostasis markers.Study Design: Combinations of 3 mg DRSP with 5 or 10 mg E4 were compared with YAZ® (20 mcg ethinyl estradiol and 3 mg DRSP; EE/DRSP) in parallel groups of 15-18 healthy young women. Main outcome was the relative change from pretreatment to the end (day 24±1) of the third treatment cycle.Results: All E4 combinations showed low estrogen impact compared to EE/DRSP. Effects on SHBG and angiotensinogen of 10 mg E4 combined with DRSP were 15%-20% that of EE/DRSP. Both E4/DRSP combinations reduced D-dimer level and the 5 mg E4/DRSP combination also decreased fragment 1+2.Conclusions: The reduction in coagulation markers suggests an anticoagulant effect from DRSP. The indications of a low thrombosis risk for E4 preparations should be validated in larger studies. IMPLICATION STATEMENT. [ABSTRACT FROM AUTHOR]

Objective: To compare the effect of ethinyl estradiol 20 microg/drospirenone 3 mg (EE 20 microg/DRSP 3 mg) administered according to a 24/4 regimen with ethinyl estradiol 20 microg/desogestrel 150 microg (EE 20 microg/DSG 150 microg) administered according to the conventional 21/7 regimen on lipid, carbohydrate and hemostatic parameters., Study Design: In this open-label study, healthy women were randomized to EE 20 microg/DRSP 3 mg or EE 20 microg/DSG 150 microg for seven cycles. Mean differences in high-density lipoprotein (HDL)- and low-density lipoprotein (LDL)-cholesterol levels at cycle 7 compared to baseline were assessed. Secondary variables included changes in other lipid, hemostatic and carbohydrate parameters., Results: Both treatments increased HDL-cholesterol, but decreased LDL-cholesterol by a comparable extent. Although slightly elevated in both groups, blood glucose and C-peptide levels measured during oral glucose tolerance tests were within normal reference ranges at cycle 7. Overall, the differences in lipid, hemostatic or carbohydrate parameters were not significant between the two treatments., Conclusion: EE 20 microg/DRSP 3 mg has a good safety profile comparable with EE 20 microg/DSG 150 microg.

Background: In contrast to traditional progestagen-only pills (POPs), the desogestrel-only pill Cerazette consistently inhibits ovulation. This study was performed to test the hypothesis that desogestrel alone will keep inhibiting ovulation even when pills are taken 12 h late, indicating that delays in tablet intake of up to 12 h do not jeopardize contraceptive efficacy., Methods: Women aged between 19 and 40 years with confirmed ovulation were admitted to this open-label pharmacodynamic study. They were treated with Cerazette for 56 days with three tablets to be taken 12 h late, having been randomized to a regimen with scheduled late tablets on Days 39, 42 and 49 (Group A) or on Days 11, 14 and 21 (Group B). The occurrence of ovulation during treatment was determined by measuring progesterone serum levels every 2 days., Results: One of the 103 treated subjects ovulated during treatment. The ovulation incidence thus amounts to 1.0% (two-sided 95% confidence interval 0.02-5.29%). There was no apparent relationship between these ovulations and scheduled late tablets. The minimum time to first posttreatment ovulation was 7 days, whereas it took 17.2 days on average from last tablet intake until ovulation., Conclusions: Ovulation inhibition with Cerazette is maintained after 12-h delays in tablet intake and return of ovulation takes at least 7 days. These properties distinguish Cerazette from all other POPs.