A Clinical Investigation Of Short-acting Combination Oral Contraceptive Yasmin

PartⅠA investigation of efficacy and acceptability of Yasmin in healthy Chinese womenExperiment one A investigation of contraceptive reliability, cycle control and tolerance of combination oral contraceptives Yasmin Objective To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral contraceptive Yasmin and compare it with a preparation Marvelon.Methods 80 women who were willing to take OCs pills for contraception were randomly divided into two groups in a ratio of 3:1. Yasmin group (DRSP/EE, n=60 ), and Marvelon group (DSG/EE, n=20 ). One tablet was taken once a day from the first day of menstrual cycle to the 21 days continually before a 7-day table-freeinterval. They will take tablets for 13 continuous cycles(1 cycle= 28 days). Subjects assessed their bleeding daily by recording episodes of vaginal bleeding in same diary card as tablets intake. Four clinic visits were scheduled during the treatment phase on days 1-7 of cycles 4, 7, and 10, and 8-14 days after cycle 13. Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of 13 cycles. Results Efficacy data of 810 treatment cycles (DRSP/EE: 650; DSG/EE: 221) were obtained from 67 women (DRSP/EE, n = 50; DSG/EE, n = 17). During the study there were no pregnancies in both groups. Both preparations provided effective contraception and good cycle control with a similarly low incidence of both spotting and breakthrough bleeding. The spotting rates in both treatment groups decreased from 12.5% (DRSP/EE) and 15% (DSG/EE) in the first treatment cycle to approximately 1.9% and 5.5% in the sixth treatment cycle. Overall, the spotting and breakthrough bleeding incidence tended to be lower with DRSP/EE than with DSG/EE. However, the difference was not statistically significant. Amenorrhea was no recorded in two groups. Both preparations were well tolerated and showed a similar pattern of adverse events.Conclusion The combination of 30 microg ethinylestradiol combined with 3 mg drospirenone(Yasmin) provide effective oral contraception and good cycle control. Both regimens provided reliable contraception and good cycle control. The incidence of adverse events was relatively low and both preparations were well tolerated.Experiment two Effects of combination oral contraceptives Yasmin on premenstrual symptomsObjective To observe monophasic oral contraceptives Yasmin on premenstrual symptoms (PMS) in childbearing-age women.Methods Women who were willing to take OCs pills for contraception were randomly divided into two groups:a Yasmin group (DRSP/EE, n=50 ), and a Marvelon group (DSG/EE, n=17 ). One pill was taken once a day from the first day of menstrual cycle to the 21 days continually before a 7-day pill-free interval. All subjects were evaluated about PMS before treatment and after six menstrual cycles by the Menstrual Distress Questionnaire (MDQ). The means of MDQ scores and their changes were calculated in two groups before treatment and after six menstrual cycles.Results Compared with those in Marvelon group, the scores of water retention and impaired concentration in the premenstrual phase in the Yasmin group was significantly drcreased with in the Marvelon group (P<0.05), while compared with those before treatment, the scores of water retention and negative affect in the premenstrual phase in the Yasmin group were obviously lower (P<0.05), as well as the scores of negative affect in the Marvelon group (P<0.05).Conclusion Yasmin could contribute more beneficially on PMS than Marvelon because of its anti-mineralocorticoid hormone effects.PartⅡEvaluation of safety of Yasmin in healthy Chinese womenObjective To observe the effect of oral contraceptives Yasmin on health women after 13 cycles treatment.Methods Subjects in partⅠ. Yasmin group(DRSP/EE , n=50) and Marvelon group(DSG/EE,n=17). All subjects were examined about laboratory examination before treatment and after 13 menstrual cycles by haemospasia and were examined about weight, blood pressure and heart rate before treatment and after 3, 6, 9 and 13 menstrual cycles. The values of laboratory examination, weight, blood pressure and heart rate and their changes were calculated in two groups before treatment and after treatment.Results1. Liver function The levels of BRT and Al were both improved in DSG/EE group after treatment(P<0.05), and especially the levels of Al was different distinctly(P≤0.01).2. Blood chemistry Compared with those in DSG/EE group, The level of sodium in blood was decreased in DRSP/EE group after treatment (P<0.01). The level of BUN in DRSP/EE was decreased after treatment(P<0.05).3. Lipid profile There were a significantly increased in TC and HDL of both groups after treatment(P<0.05).4. Blood glucose There was no obvious difference in the levels of fasting blood glucose both groups after treatment.5. Complete blood count There was no obvious difference in the levels of complete blood count both groups after treatment.6. Compared with those in DSG/EE group,weight was significantly decreased in DRSP/EE group after 13 menstrual cycles. (P<0.05)Conclusion The effect of the third generation oral contraceptive containing DRSP or DSG on metabolism was relatively low. Yasmin had a more favorable effect on body weight than Marvelon, with the mean body weight remaining lower than baseline for the majority of the women. Yasnim are less disadvantageous to women's health in comparision with Marvelon.PartⅢEffects of Yasmin on cytokines of serum in women and explore its mechanisms of contraceptionObjective To observe the effects of Yasmin and Marvelon on immune function of women, and to explore their mechanisms of contraception.Methods 40 women who taking oral contraceptives for 13 cycles in partⅠ(EE/DRSP, n = 25; EE/DSG, n = 15) as trials and 20 healthy women as controls were studied. The cytokines IL-2,IL-6,TNFαand IFN-γwere tested by ELISA.Results Compared with those in control group , the level of TNFαwas significantly increased and the levels of IL-6 was significantly decreased in trial group(P<0.05). The levels of IFN-γin EE/DRSP group was significantly increased then those in control group (P<0.05).There was a slight increased of IFN-γlevel in EE/DSG then those in control group, but not significantly different. The levels of IL-2 in trial group were not different from control group.Conclusion After 13 cycles of taking oral contraceptives Yasmin and Marvelon showed some influence on the cellular immunity in women, but had no harmful effect. Cytokines accommodate internal environment of uterus by autocrine or paracrine and contral action of steroid hormone on nidation might be one of the mechanisms of contraception of combination oral contraceptives.