2.7 Other Safety Variables Other laboratory assessments conducted include hematology, plasma chemistry, liver enzymes, sex hormone-binding globulin, and carbohydrate and lipid metabolism. Adverse events were assessed throughout the study for each treatment. Other safety parameters included gynecological findings, vital signs, body weight, BMI, and cervical smear results. 2.8 Treatment Compliance Women were required to record the number of COC tablets

(0, 1, or 2) taken each day, the dates new patches were applied, the patch application site, patch application deviations, the reason for patch removal (if applicable), the dates they did not wear a patch, and whether back-up contraception SRT1720 was used. Patch adhesion (e.g., the number of completely and partially detached patches per cycle) was also recorded. 2.9 Statistical Analyses All treatment variables were analyzed using descriptive statistical methods. The primary analyses of this study were performed on the absolute changes from corresponding baseline values for the two primary variables (prothrombin fragments 1 + 2 and d-dimer). A normal distribution was assumed for the absolute

change in each parameter. The treatment effect in either variable was investigated using an ANOVA model to test for a treatment difference for each variable. Bonferroni correction was used to account for multiple testing; therefore, for each of the two primary hemostatic parameters, a 97.5 % two-sided

Selleck Metabolism inhibitor confidence interval was derived for the treatment difference. For Oxalosuccinic acid the secondary variables, descriptive analyses of the absolute and relative changes from corresponding baseline values were conducted. While a sample size of 30 women was chosen without formal statistical power considerations, this number is commonly used for metabolic studies on contraceptives. All women who received study drug, and for whom data from any treatment period were available, were included in the full analysis set (FAS). The primary analysis of this study was based on the FAS; this population was also used for evaluation of safety data. 3 Results 3.1 Subject Disposition and Demographics A total of 48 women were enrolled onto the study. Of these women, 18 did not pass the screening process, and 30 were randomized for treatment (Fig. 2). In total, 15 women were assigned to each of treatment sequences A and B. One woman chose to withdraw from the study prior to treatment (sequence B), and 29 women either started treatment or, for those who had used a method of hormonal contraception prior to screening, performed the first washout phase and then started treatment period 1. For five women in treatment sequence A and three women in treatment sequence B, previous use of hormonal contraception was reported and a first washout phase required.