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Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100μg levonorgestrel and 20 μg ethinyl estradiol in woman 35 and over
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P3.04.05 EFFECTS OF TRIMONTHLY INJECTABLE OF DEPOMEDROXYPROGESTERONE ACETATE (DMPA) ON CARBOHYDRATE METABOLISM NR Melo, RM Burgos, LM Pompei, WM Ari&, W Pinheiro, AZ Melo, HW Halbe, JA Pinotti Medicine School of SBo Paula University, Brasil Objective: To study the effect of trimonthly injectable contraceptive consisting of 150 mg of depot-medroxyprogesterone acetate (DMPA) on carbohydrate metabolism. Methods: Forty-six DMPA-user patients were studied retrospectively. Their average age was 44.4 and they used DMPA as contraceptive for at least 5 years (average use duration: 10.6 years). The dose of DMPA was 150 mg every 3 months. To evaluate carbohydrate metabolism, it was obtained Quetelet’s index, abdomen-gluteus ratio, glycemia, serum insulin and glycoside-hemoglobin. It was used a group of 126 intrauterine-device-user women (IUD), with average age of 43.5 years, as control to comparison. Results: The mean results of DMPA-group and control-group were: Quetelet’s index was 27.79 in DMPA users and 27.41 in control group. Abdome-gluteus ratio was the same in both groups (0.94). Glycemia was lesser (92.13 mgidl) in DMPA than in control (96.11 mgidl), but it was normal in both groups (normal between 70 and 110 mgidl). Serum insulin was 15.24 mcIU/ml in injectable group and 15.65 mcIU/ml in control, but in both it was normal (less than 20 mcIU/ml). Finally, glycoside-hemoglobin was 6.06% in the study group and 6.18% in control group. The differences between the two groups, when present, had not statistic significance. Conclusions: The DMPA used in a trimonthly injectable form with doses of 150 mg did not affect adversely the studied carbohydrate metabolism parameters.
P3.04.06 EFFICACY AND SAFETY OF A LOW-DOSE MONOPHASIC COMBINATION ORAL CONTRACEPTIVE CONTAINING 1OOpg LEVONORGESTREL AND 20 pg ETHINYL ESTRADIOL IN WOMAN 35 AND OVER A. DelConte (l), D. F. Archer(2), (1) Wyeth-Ayerst Research, St. Davids, PA, USA. (2) Jones Institute for Reproductive Medicine, Norfolk, VA, USA. Objective: To evaluate the efficacy and safety of a low-dose, 21.day combination oral contraceptive containing 1OOpg of levonorgestrel (LNG) and 20 pg of ethinyl estradiol (EE) in women 35 and older. Study Methods: Women (1,708) age 15 and older with regular menstrual cycles were administered a 21.day combination oral contraceptive containing 100 pg LNGI2Opg EE for 3 years. The efficacy and safety of the OC was evaluated in a subset of 218 women age 35 and older. Results: During 3,859 cycles evaluated for efficacy, 1 pregnancy occurred (Pearl index = 0.34). This is consistent with the Pearl indexes compiled from other studies with 100 pg LNGI20 pg EE (range 0.2 to 0.9). Breakthrough bleeding (with or without spotting) occurred in 11.3% of the cycles, and spotting alone occurred in 11.5% of the 3,859 cycles evaluated. The two most common adverse events cited as reasons for discontinuation were hypertension (3% of subjects) and metrorrhagia (2%). Conclusions: Overall, the results of this study demonstrate that the lowdose, monophasic regimen of 100 pg LNGI20 pg EE offers effective contraception, acceptable cycle control, and good tolerability in women age 35 and older.
P3.04.07 EFFICACY OF MISOPROSTOL CERVICAL PREPARATION AND MANUAL VACUUM ASPIRATION FOR EARLY SECOND TRIMESTER TERMINATIONS C.S. Todd, M.E. Soler, L.D. Castleman, M.K. Rogers, P.D. Blumenthal Johns Hopkins Bayview Medical Center, Baltimore, MD, U.S.A. Objective: To determine the efficacy of using manual vacuum aspiration for abortion up to 18 weeks gestation after cervical preparation with misoprostol. Methods: Subjects were obtained from a case series of over 100 patients presenting for dilatation and evacuation at Johns Hopkins Bayview
WEDNESDAY,
SEPTEMBER
6
Medical center. 8OOpg of buccal misoprostol was given for cervical preparation. Dilatation and evacuation was then performed using manual vacuum aspiration primarily to remove amniotic fluid and placenta. Fetal parts were removed as necessary with appropriate forceps. Results: Complete abortion was effected in 100% of cases. No cases required resorting to an electric vacuum source. In all cases, the cervix was adequately prepared to allow either the immediate introduction of a size 14 mm suction can&a or could be easily dilated to allow passage of same. Procedure time was not significantly different when manual vacuum source was used than that for procedures in which an electric vacuum source was used. Conclusion: Although manual vacuum aspiration (MVA) is known to be safe and effective for termination of pregnancy in the first trimester, this report indicates that it can also be safely and effectively used in 2”d trimester procedures. This is important for settings where electric vacuum sources are either unavailable, unreliable, or cannot accommodate the large bore equipment required for D&E procedures. Similarly, the use of misoprostol to provide cervical preparation, was effective and offers an alternative in settings where laminaria are not available. MVA and buccal misoprostol should be more widely investigated for this purpose.
P3.04.08 EVALUATION OF LIPIDIC PROFILE IN TEENAGE LONG TERM USERS OF ORAL HORMONAL CONTRACEPTIVE C. Guazzelli, P.C. Lindsey, F.F. Aratijo, R.M. Santana, R. Mattar, M. Barbieri, L. Kulay Jr., Family Planning Service, Federal University of SBo Paula, EPM, Brazil. Objectives: In adolescence, the beginning of the association of factors of risk for cardiovascular diseases is frequently observed. In this period of life important transformations occur, such as changes in food ingestion and physical activity habits, initiation to smoking, alcohol abuse and sex. Such modifications can have repercussions throughout life, the most hazardous of which leads to arterosclerosis. Early commencement of sexual activity combined with the frequent use of oral hormonal contraceptives by teens has concerned specialists, mainly if used for long periods. Oral hormonal contraception has widespread use among teenagers because of its high effectiveness, facility of use and also due to benefits related to the menstrual cycle, dysmenorrhea and acne. Bearing in mind the importance of this subject, we decided to investigate the effects of monophasic combined OHC containing 30 pg of etinilestradiol and 75 pg of gestodene over teenagers lipidic metabolism. Study Methods: 33 young women aged 14 to 19 years, users of OHC for a period of three years were evaluated. These parameters were analyzed: total cholesterol, HDL-C, LDL-C, VLDL-C, triglycerides, Castelli I and II risk indices. These exams were performed before starting OHC and one, two and three years after utilization of the method. Results: Statistical analysis showed an increase in total cholesterol, HDL-C, LDL-C, VLDL-C and triglyceride levels when compared to the initial values of one, two and three years of utilization of OHC. Indeed, the averages didn’t exceed normal ranges. No significant statistical variation in Castelli I and II indices was found. Conclusion: The use of combined monophasic hormonal oral contraceptive containing 30 pg of etinilestradiol and 75 pg of gestodene over a period of three years causes an increase in total cholesterol levels, its fractions and triglycerides. These data emphasize the importance of evaluation of lipidic profile before and periodically during the use of OHC in order to get better follow-up and prevention of cardiovascular diseases.
P3.04.09 EVALUATION OF THE EFFECTIVENESS AND ACCEPTABILITY OF THE DIAPHRAGM AS CONTRACEPTIVE METHOD NR Melo, RM Burgos, LM Pompei, ML Elluf, P Nicolau, LO Ramos, JA Pinotti, Medicine School of SBo Paula University, Brasil Objectives: To evaluate the contraceptive effectiveness and the acceptability of diaphragm. Methods: They were retrospectively studied 44 women that used the diaphragm as contraceptive method, and 84.1% used spermicide gel associately. Everyone received exhausting orientation for correct way of employment of the method. The time of use varied from 10 to 121 months (average: 45.3 months), being equal to 124.6 woman-years.
P3.04.05 EFFECTS OF TRIMONTHLY INJECTABLE OF DEPOMEDROXYPROGESTERONE ACETATE (DMPA) ON CARBOHYDRATE METABOLISM NR Melo, RM Burgos, LM Pompei, WM Ari&, W Pinheiro, AZ Melo, HW Halbe, JA Pinotti Medicine School of SBo Paula University, Brasil Objective: To study the effect of trimonthly injectable contraceptive consisting of 150 mg of depot-medroxyprogesterone acetate (DMPA) on carbohydrate metabolism. Methods: Forty-six DMPA-user patients were studied retrospectively. Their average age was 44.4 and they used DMPA as contraceptive for at least 5 years (average use duration: 10.6 years). The dose of DMPA was 150 mg every 3 months. To evaluate carbohydrate metabolism, it was obtained Quetelet’s index, abdomen-gluteus ratio, glycemia, serum insulin and glycoside-hemoglobin. It was used a group of 126 intrauterine-device-user women (IUD), with average age of 43.5 years, as control to comparison. Results: The mean results of DMPA-group and control-group were: Quetelet’s index was 27.79 in DMPA users and 27.41 in control group. Abdome-gluteus ratio was the same in both groups (0.94). Glycemia was lesser (92.13 mgidl) in DMPA than in control (96.11 mgidl), but it was normal in both groups (normal between 70 and 110 mgidl). Serum insulin was 15.24 mcIU/ml in injectable group and 15.65 mcIU/ml in control, but in both it was normal (less than 20 mcIU/ml). Finally, glycoside-hemoglobin was 6.06% in the study group and 6.18% in control group. The differences between the two groups, when present, had not statistic significance. Conclusions: The DMPA used in a trimonthly injectable form with doses of 150 mg did not affect adversely the studied carbohydrate metabolism parameters.
P3.04.06 EFFICACY AND SAFETY OF A LOW-DOSE MONOPHASIC COMBINATION ORAL CONTRACEPTIVE CONTAINING 1OOpg LEVONORGESTREL AND 20 pg ETHINYL ESTRADIOL IN WOMAN 35 AND OVER A. DelConte (l), D. F. Archer(2), (1) Wyeth-Ayerst Research, St. Davids, PA, USA. (2) Jones Institute for Reproductive Medicine, Norfolk, VA, USA. Objective: To evaluate the efficacy and safety of a low-dose, 21.day combination oral contraceptive containing 1OOpg of levonorgestrel (LNG) and 20 pg of ethinyl estradiol (EE) in women 35 and older. Study Methods: Women (1,708) age 15 and older with regular menstrual cycles were administered a 21.day combination oral contraceptive containing 100 pg LNGI2Opg EE for 3 years. The efficacy and safety of the OC was evaluated in a subset of 218 women age 35 and older. Results: During 3,859 cycles evaluated for efficacy, 1 pregnancy occurred (Pearl index = 0.34). This is consistent with the Pearl indexes compiled from other studies with 100 pg LNGI20 pg EE (range 0.2 to 0.9). Breakthrough bleeding (with or without spotting) occurred in 11.3% of the cycles, and spotting alone occurred in 11.5% of the 3,859 cycles evaluated. The two most common adverse events cited as reasons for discontinuation were hypertension (3% of subjects) and metrorrhagia (2%). Conclusions: Overall, the results of this study demonstrate that the lowdose, monophasic regimen of 100 pg LNGI20 pg EE offers effective contraception, acceptable cycle control, and good tolerability in women age 35 and older.
P3.04.07 EFFICACY OF MISOPROSTOL CERVICAL PREPARATION AND MANUAL VACUUM ASPIRATION FOR EARLY SECOND TRIMESTER TERMINATIONS C.S. Todd, M.E. Soler, L.D. Castleman, M.K. Rogers, P.D. Blumenthal Johns Hopkins Bayview Medical Center, Baltimore, MD, U.S.A. Objective: To determine the efficacy of using manual vacuum aspiration for abortion up to 18 weeks gestation after cervical preparation with misoprostol. Methods: Subjects were obtained from a case series of over 100 patients presenting for dilatation and evacuation at Johns Hopkins Bayview
WEDNESDAY,
SEPTEMBER
6
Medical center. 8OOpg of buccal misoprostol was given for cervical preparation. Dilatation and evacuation was then performed using manual vacuum aspiration primarily to remove amniotic fluid and placenta. Fetal parts were removed as necessary with appropriate forceps. Results: Complete abortion was effected in 100% of cases. No cases required resorting to an electric vacuum source. In all cases, the cervix was adequately prepared to allow either the immediate introduction of a size 14 mm suction can&a or could be easily dilated to allow passage of same. Procedure time was not significantly different when manual vacuum source was used than that for procedures in which an electric vacuum source was used. Conclusion: Although manual vacuum aspiration (MVA) is known to be safe and effective for termination of pregnancy in the first trimester, this report indicates that it can also be safely and effectively used in 2”d trimester procedures. This is important for settings where electric vacuum sources are either unavailable, unreliable, or cannot accommodate the large bore equipment required for D&E procedures. Similarly, the use of misoprostol to provide cervical preparation, was effective and offers an alternative in settings where laminaria are not available. MVA and buccal misoprostol should be more widely investigated for this purpose.
P3.04.08 EVALUATION OF LIPIDIC PROFILE IN TEENAGE LONG TERM USERS OF ORAL HORMONAL CONTRACEPTIVE C. Guazzelli, P.C. Lindsey, F.F. Aratijo, R.M. Santana, R. Mattar, M. Barbieri, L. Kulay Jr., Family Planning Service, Federal University of SBo Paula, EPM, Brazil. Objectives: In adolescence, the beginning of the association of factors of risk for cardiovascular diseases is frequently observed. In this period of life important transformations occur, such as changes in food ingestion and physical activity habits, initiation to smoking, alcohol abuse and sex. Such modifications can have repercussions throughout life, the most hazardous of which leads to arterosclerosis. Early commencement of sexual activity combined with the frequent use of oral hormonal contraceptives by teens has concerned specialists, mainly if used for long periods. Oral hormonal contraception has widespread use among teenagers because of its high effectiveness, facility of use and also due to benefits related to the menstrual cycle, dysmenorrhea and acne. Bearing in mind the importance of this subject, we decided to investigate the effects of monophasic combined OHC containing 30 pg of etinilestradiol and 75 pg of gestodene over teenagers lipidic metabolism. Study Methods: 33 young women aged 14 to 19 years, users of OHC for a period of three years were evaluated. These parameters were analyzed: total cholesterol, HDL-C, LDL-C, VLDL-C, triglycerides, Castelli I and II risk indices. These exams were performed before starting OHC and one, two and three years after utilization of the method. Results: Statistical analysis showed an increase in total cholesterol, HDL-C, LDL-C, VLDL-C and triglyceride levels when compared to the initial values of one, two and three years of utilization of OHC. Indeed, the averages didn’t exceed normal ranges. No significant statistical variation in Castelli I and II indices was found. Conclusion: The use of combined monophasic hormonal oral contraceptive containing 30 pg of etinilestradiol and 75 pg of gestodene over a period of three years causes an increase in total cholesterol levels, its fractions and triglycerides. These data emphasize the importance of evaluation of lipidic profile before and periodically during the use of OHC in order to get better follow-up and prevention of cardiovascular diseases.
P3.04.09 EVALUATION OF THE EFFECTIVENESS AND ACCEPTABILITY OF THE DIAPHRAGM AS CONTRACEPTIVE METHOD NR Melo, RM Burgos, LM Pompei, ML Elluf, P Nicolau, LO Ramos, JA Pinotti, Medicine School of SBo Paula University, Brasil Objectives: To evaluate the contraceptive effectiveness and the acceptability of diaphragm. Methods: They were retrospectively studied 44 women that used the diaphragm as contraceptive method, and 84.1% used spermicide gel associately. Everyone received exhausting orientation for correct way of employment of the method. The time of use varied from 10 to 121 months (average: 45.3 months), being equal to 124.6 woman-years.