A Prospective Study On The Combined Oral Contraceptives Containing Lower Dosage Of Ethinylestradiol/Levonorgestrel

Part I Efficacy, compliance and tolerance of the combined oral contraceptives containing lower dosage of Ethinylestradiol/LevonorgestrelObjectives: To evaluate contraceptive efficacy, compliance and tolerance of the 0.02 mg EE/0.10 mg LNG.Methods: A total of 70 subjects who were conformed to the inclusion and exclusion criteria and willing to take the oral contraceptive pills were evaluated. They were random Ly divided into the test group(0.02 mg EE/0.10 mg LNG) and the control group(0.03 mg EE/0.15 mg LNG), which contained 52 cases and 18 cases respectively.The oral contraceptives was administered at the first day of the menstrual cycle and once a day for 21 days, followed by 7 days of placebo for a complete cycle. All participants would complete 13 cycles. Each woman completed a daily diary that included the number of drugs, side effects and vaginal bleeding when each pill was taken.Subjects were asked to visit at 2, 5, 8, 11 cycles before the first 1~7 days and after completing 13 cycles 7 days.Results: A total of 70 women were treated for 516 cycles, including 370 cycles in the experimental group and 146 cycles in the control group from July 9th, 2014 to March 1st, 2016. No pregnancies occurred with the two groups.One or more active pills were missed during 23(6.22%) cycles in the experimental group, 8.9% in higher dosage group.Three subjects missed ≥ 3 consecutive active pills in a cycle during the experimental group. 11 subjects discontinued this trial due to a variety of reasons. As compared to women using 0.02 mg EE preparations, those using the 0.03 mg EE preparations experienced considerably more frequent side effects. Abdominal distension was consistently higher frequency in the control group than in the experimental group(P ≤ 0.01).The incidence of side effects reduced with the extension of drug cycle in the first 10 cycles.Conclusion: Both groups have a good contraceptive effectiveness and acceptability. The experimental group has better tolerance than the control group by a lower incidence of side effects.Part II An assessment of the effect of lower dosage of Ethinylestradiol/Levonorgestrel on cycle control and the premenstrual syndromeObjectives: To evaluate the impact of 0.02 mg EE/0.10 mg LNG on cycle control and the premenstrual syndrome.Methods: Vaginal bleeding data from women who received either 0.02 mg EE/0.10 mg LNG(n = 25) or 0.03 mg EE/0.15 mg LNG(n = 11) were pooled and analysed over nine treatment cycles in accordance with the daily diary.Women who completed seven cycles in part I, in which the experimental group 34 cases and the control group 14 cases were selected to assess the impact of combined oral contraceptives on the physical, psychological and behavioral symptoms according to the scores of MDQ.Results: There was no amenorrhea in both groups.The menstrual cycle of test group shortened statistically significant(P < 0.05)after taking 2 and 8 medication cycles compared to no medication.There was not statistical difference in the control group.The menstrual duration of the control group is significantly shorter than the experimental group in cycle 5, but subjects could accept it.Spotting was more common among the lower dosage group, with a mean incidence of 4.44% compared to 2.02% in the higher dosage group.The incidence of unscheduled intracyclic bleeding was declining along with the extension of medication cycle and there was no statistically significant for the two treatment groups. No statistically significant was found between before and after treatment in the total scores of MDQ except the feelings of well-being,but the score of after treatment was lower than no medicine. Both groups had significant difference on inattention during the intermenstrual phase and the premenstrual phase after treatment(P < 0.05).Conclusion: Both groups could effectively control the menstrual cycle.The 0.02 mg EE/0.10 mg LNG group has higher percentage of irregular bleeding than the control group.In the aspect of the premenstrual syndrome,both groups had no significant effect on the MDQ after medicine and the control group may have more effective on improving inattention than the the test group.Part III Safety of the lower dosage of Ethinylestradiol/LevonorgestrelExperiment one Effects on lipid metabolism and blood clotting of the lower dosage of Ethinylestradiol/LevonorgestrelObjectives: To assess the effect of 0.02 mg EE/0.10 mg LNG on lipid metabolism and blood clotting.Methods: Datas from 48 volunteers were obtained(0.02 mg EE/0.10 mg LNG, n = 34; 0.03 mg EE/0.15 mg LNG, n = 14). Blood samples for the assessment of blood clotting, blood biochemical and blood routine were taken before treatment and in cycle 8.Samples were drawn following a 12 hour overnight fast.Weight, blood pressure and heart rate were taken during the pretreatment cycle, treatment cycles 2,5and 8(on cycle days 1 to 7).Results: No appreciable difference between the groups was found on basic vital signs,blood routine and blood biochemical.Levels of PT and APTT decreased significantly in both groups after 7 cycles compared with no medicine, and a significantly increases was seen in TT. However, mean levels of those parameters remained within the normal range in both treatment groups. No significant differences between the treatment groups for any of the laboratory parameters were found.Conclusion: It may not have the clinical significance of metabolism and blood coagulation after taking 0.02 mg EE/0.10 mg LNG 7 cycles.Experiment two Leptin and adiponectin evaluation in Ethinylestradiol/LevonorgestrelObjectives: The purpose of this study was to evaluate serum ADP, LEP levels and the correlation between adipokines and lipid profiles in women receiving 0.02 mg EE/0.10 mg LNG and 0.03 mg EE/0.15 mg LNG.Methods: Twenty eight healthy women who haven not taken COCs as the non-medication group. Twenty eight healthy women who visit in the same period of the menstrual cycle after 7 cycles were enrolled in this study(the medicine group 1, n = 20; the medicine group 2, n = 8). Fasting blood sample was collected from both groups for quantitative determination of serum LEP and ADP by ELISA.The determination of lipid metabolism was identical with experiment one of part III.Results: ADP showed significantly negative correlation with TC, LDL and Castelli index I.There was not significant difference in the medicine group 1, the medicine group 2 and the non-medication group.Conclusion: Adiponectin may be involved in regulation of lipid metabolism.The levels of LEP, ADP and ADP/LEP may not be influenced after taking EE/LNG 7 cycles.These observations must be extended in large scale study, the period of medication and controlled interference factors to confirm the effect of EE/LNG on adipokines.