Analysis set (n = 86) Received study treatment (n = 86)Prematurely discontinued remedy (n = 7) Adverse events (n = two) Withdrew consent (n = 3) Relocation (n = 2)Prematurely discontinued treatment (n = 5) Adverse events (n = 4) Main protocol deviation (n = 1)Study completed (n = 79)Study completed (n = 81)Per protocol set (n = 75)Per protocol set (n = 75)Figure two Disposition of women throughout the study. Abbreviations: drsp, drospirenone; EE, ethinylestradiol.submit your manuscript | www.dovepressInternational Journal of Women’s Health 2013:DovepressDovepressEE-drospirenone-levomefolate calcium versus EE-drospirenone + folic acid(all of which had been on account of missing valid data) have been noted in 11 women in each and every therapy group. Analysis from the major variables was performed in 150 ladies (EE-drospirenonelevomefolate calcium, n = 75; EE-drospirenone + folic acid, n = 75) who showed no main protocol deviations and comprised the per protocol set. All study participants had been Caucasian having a mean age of 27.7 (variety 180) years. Baseline and demographic traits for the per protocol set are reported in Table 1 and had been comparable with those in the full analysis set (information not shown).α-Chaconine Protocol Compliance was higher in each treatment groups more than 44 weeks (11 cycles); the array of signifies was 27.68.1 tablets/capsules per 28-day cycle. Nutrition assessments were offered for 150 girls. Mean total dietary folate intake was not substantially various at the four assessment time points (range 0.176 0.070 to 0.209 0.196 mg/day).Table 2 Area below the folate concentration-time curve from time 0 (baseline) to week 24 (AUC(04 weeks)) for plasma and RBC folate (uncorrected and corrected for baseline folate concentrations) after administration of EE-drospirenone-levomefolate calcium or EE-drospirenone + folic acid for 24 weeks (invasion phase; per protocol set)Plasma folate AUC(04 weeks) (nmol week/L) RBC folate AUC(04 weeks) (nmol week/L)BaselineBaseline- BaselineBaselineuncorrected corrected uncorrected corrected 1030 (24.0) 640 (29.0) 24,176 (21.8) ten,427 EE-drsp(34.three) levomefolate calcium (n = 75) 904 (22.three) 561 (32.7) 21,876 (17.7) 8863 EE-drsp + (24.six) folic acid (n = 75)Note: Information presented as geometric mean ( geometric coefficient of variation). Abbreviation: AUC, area beneath the concentration-time curve; drsp, drospirenone; EE, ethinylestradiol; RBC, red blood cell.Plasma and RBC folate exposure through the invasion phaseThe geometric imply AUC(04 weeks) for plasma and RBC folate were generally comparable following therapy with EE-drospirenone-levomefolate calcium and EEdrospirenone + folic acid (baseline-uncorrected and baseline-corrected values, Table 2).Gadolinium Biological Activity In both remedy groups, variability was higher for baseline-corrected values of AUC(04 weeks) for plasma and RBC folate.PMID:23916866 The geometric mean ratios (EE-drospirenone-levomefolate calcium versus EE-drospirenone + folic acid) for baselineuncorrected and baseline-corrected plasma AUC(04 weeks) have been 114 (two-sided 90 CI 107 21 ) and 114 (two-sided 90 CI 105 24 ), respectively. Exposure was equivalent involving treatments working with bioequivalence criteria (defined as two-sided 90 CI limits of 80 25 ); corresponding geometric imply ratios for baseline-uncorrected and baseline-corrected RBC folate AUC(04 weeks)have been 111 (two-sided 90 CI 105 17 ) and 118 (two-sided 90 CI 109 27 ), respectively.Plasma and RBC folate concentrationsInvasion phaseThe mean concentration-time curves for plasma folate and RBC folate.
