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4 regimen: a pooled analysis of four, open-label studies
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Poster presentations / International Journal of Gynecology & Obstetrics 107S2 (2009) S413–S729
pregnancies is the source of disagreement among obstetricians and other healthcare providers. Others believe that an interval of 18–24 months between pregnancies is optimal for the health of the mother and fetus, but the scientific evidence for this is weak. It is still unclear whether short inter-pregnancy interval is a marker for poor pregnancy outcome or a direct risk factor for poor perinatal outcome. Objective: To determine the optimal length of interval between pregnancies that would prevent adverse perinatal outcome. Study design: Cross Sectional study. Methodology: Conducted from September 1 to December 31, 2002. A total of 216 women who had two consecutive singleton pregnancies of which the second of each pair is the current pregnancy and delivered during the study period were included in the study. The outcome of the second of each pair of pregnancies and the length of time between each pregnancy were determined. Statistical analysis: Fischer exact test, Chi-Square Test and Relative Risk at 95% confidence interval. Result: There was significant association between low birth weight infants and extremes of pregnancy interval: 4× risk for <1 year interval (RR = 3.60 95% CI = 1.66–7.77) and 6× risk for >10 yrs interval (RR = 5.75 95% CI = 2.54–13.14) with p values of <0.001 and <0.03 respectively. Conclusion: There was significant association between long and short inter-pregnancy interval and low birth weight (LBW) infants. P734 A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 mcg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 mcg/drospirenone 3 mg administered in a 24/4 regimen G. Bachmann1 , M. Kunz2 , J. Marr2 . 1 University of Medicine and Dentistry of New Jersey, 2 Bayer Schering Pharma AG Objectives: To compare the cycle control of an oral contraceptive (OC) containing ethinylestradiol (EE) 30 mcg/drospirenone (drsp) 3 mg administered in a 21/7 regimen versus a lower-dose OC containing EE 20 mcg/drsp 3 mg administered in a 24/4 regimen, based on historical data from two identically-designed studies. Materials and Methods: In the first study, 326 healthy women aged 18–35 years received the OC containing EE 30 mcg/drsp 3 mg in 21/7 regimen. In the second study, 1027 healthy women aged 17–36 years received the OC containing EE 20 mcg/drsp 3 mg in a 24/4 regimen. In both studies, all women recorded bleeding daily prospectively over 13 treatment cycles. Results: The proportion of women who experienced intracyclic bleeding was highest in cycle 1, with 24.8% in the EE 30 mcg/drsp 3 mg 21/7 regimen OC group and 24.7% in the EE 20 mcg/drsp 3 mg 24/4 regimen OC group reporting this event. The proportion of women with intracyclic bleeding fell by approximately 50% with both OCs from cycle 1 to 4, and remained fairly stable thereafter. During cycles 4–13, the proportion of women who experienced intracyclic bleeding ranged between 7.9–13.1% in the EE 30 mcg/drsp 3 mg 21/7 regimen OC group and 8.9–13.8% in the EE 20 mcg/drsp 3 mg 24/4 regimen OC group. Conclusions: A low-dose OC containing EE 20 mcg/drsp 3 mg administered in 24/4 regimen appears to have similar cycle control to a higher-dose OC containing EE 30 mcg/drsp 3 mg administered in 21/7 regimen.
P735 Contraceptive efficacy of a combined oral contraceptive containing ethinylestradiol 20 mcg/drospirenone 3 mg administered in 24/4 regimen: a pooled analysis of four, open-label studies L. Anttila1 , M. Kunz2 , J. Marr2 . 1 The Family Federation of Finland, Turku Clinic, 2 Bayer Schering Pharma AG Objectives: To determine the contraceptive efficacy of a combined oral contraceptive (COC) containing ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ), based on a pooled analysis of four, phase III studies. Materials and Methods: A total of 2386 healthy women aged 18– 35 years requesting contraception were included in four, openlabel studies; two randomized, comparative studies and two noncomparative studies. The duration of the studies ranged between 7 and 13 cycles. Contraceptive efficacy was determined using the Pearl Index (PI) and the cumulative probability of pregnancy. Results: A total of 16 pregnancies occurred during 729,537 days’ treatment exposure resulting in a PI of 0.80 (upper limit of the 95% CI: 1.30). Of these pregnancies, 7 were attributed to compliance issues during a treatment exposure time of 616,607 days, resulting in an adjusted PI of 0.41 (upper limit of the 95% CI: 0.85). The cumulative 1-year pregnancy rate was 0.0079 (95% CI: 0.0048; 0.0129). Conclusion: The low-dose COC containing EE 20 mcg/drsp 3 mg administered in 24/4 regimen provides excellent contraceptive efficacy. P736 Contraceptive consciousness among Polish population at the beginning of 21st century R. Matusiak1 , I. Szymusik1 , K. Kosinska-Kaczynska1 , K. Matusiak2 , E. Horosz1 . 1 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland, 2 Students’ Research Group at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland Objective: The aim of the study was to assess the knowledge of contraceptive methods(CM) among Polish population. Material and Methods: The study was carried out on the basis of authors’ inquiry among 185 women (W; aged 14–64; mean 30.51±10.3) and 150 men (M; aged 15–61, mean 29.26±8.6). It consisted of 18 questions concerning sexual life and CM. The majority of respondents came from the cities and were of university or high school education. Results: The majority of respondents were sexually active (W 78%; M 87%) and most of them used contraception (W 68%; M 74%). Condoms are the most common CM among men (56%). Oral ontraception (OC) is most frequently used by females (34%). However, male respondents significantly more often choose coitus interruptus as CM (12% vs 0.5%W; p < 0.05). Women usually gain information about CM from their doctors (67%) and magazines (41%). The most common sources for men are: internet (42%), magazines (37%) and TV (28%). Only 14%W and 11%M know about contraceptive implants. Every fifth men has heard about injectable CM. 70% of respondents want to know more about CM, especially the less frequently used ones. OC is regarded as most effective by 48% W and 28% M (p < 0.05). However, only 5% W consider condoms effective in comparison to 24% M (p < 0.05). Efficacy and lack of side effects are the most important characteristics of CM for all the respondents. Female respondents significantly more often pay attention the cost (11% vs 5%; p < 0.05). Conclusions: The knowledge of CM is satisfactory among Polish population. At the same time there is a need of constant education about all the existing methods. Health care in Poland should
Poster presentations / International Journal of Gynecology & Obstetrics 107S2 (2009) S413–S729
pregnancies is the source of disagreement among obstetricians and other healthcare providers. Others believe that an interval of 18–24 months between pregnancies is optimal for the health of the mother and fetus, but the scientific evidence for this is weak. It is still unclear whether short inter-pregnancy interval is a marker for poor pregnancy outcome or a direct risk factor for poor perinatal outcome. Objective: To determine the optimal length of interval between pregnancies that would prevent adverse perinatal outcome. Study design: Cross Sectional study. Methodology: Conducted from September 1 to December 31, 2002. A total of 216 women who had two consecutive singleton pregnancies of which the second of each pair is the current pregnancy and delivered during the study period were included in the study. The outcome of the second of each pair of pregnancies and the length of time between each pregnancy were determined. Statistical analysis: Fischer exact test, Chi-Square Test and Relative Risk at 95% confidence interval. Result: There was significant association between low birth weight infants and extremes of pregnancy interval: 4× risk for <1 year interval (RR = 3.60 95% CI = 1.66–7.77) and 6× risk for >10 yrs interval (RR = 5.75 95% CI = 2.54–13.14) with p values of <0.001 and <0.03 respectively. Conclusion: There was significant association between long and short inter-pregnancy interval and low birth weight (LBW) infants. P734 A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 mcg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 mcg/drospirenone 3 mg administered in a 24/4 regimen G. Bachmann1 , M. Kunz2 , J. Marr2 . 1 University of Medicine and Dentistry of New Jersey, 2 Bayer Schering Pharma AG Objectives: To compare the cycle control of an oral contraceptive (OC) containing ethinylestradiol (EE) 30 mcg/drospirenone (drsp) 3 mg administered in a 21/7 regimen versus a lower-dose OC containing EE 20 mcg/drsp 3 mg administered in a 24/4 regimen, based on historical data from two identically-designed studies. Materials and Methods: In the first study, 326 healthy women aged 18–35 years received the OC containing EE 30 mcg/drsp 3 mg in 21/7 regimen. In the second study, 1027 healthy women aged 17–36 years received the OC containing EE 20 mcg/drsp 3 mg in a 24/4 regimen. In both studies, all women recorded bleeding daily prospectively over 13 treatment cycles. Results: The proportion of women who experienced intracyclic bleeding was highest in cycle 1, with 24.8% in the EE 30 mcg/drsp 3 mg 21/7 regimen OC group and 24.7% in the EE 20 mcg/drsp 3 mg 24/4 regimen OC group reporting this event. The proportion of women with intracyclic bleeding fell by approximately 50% with both OCs from cycle 1 to 4, and remained fairly stable thereafter. During cycles 4–13, the proportion of women who experienced intracyclic bleeding ranged between 7.9–13.1% in the EE 30 mcg/drsp 3 mg 21/7 regimen OC group and 8.9–13.8% in the EE 20 mcg/drsp 3 mg 24/4 regimen OC group. Conclusions: A low-dose OC containing EE 20 mcg/drsp 3 mg administered in 24/4 regimen appears to have similar cycle control to a higher-dose OC containing EE 30 mcg/drsp 3 mg administered in 21/7 regimen.
P735 Contraceptive efficacy of a combined oral contraceptive containing ethinylestradiol 20 mcg/drospirenone 3 mg administered in 24/4 regimen: a pooled analysis of four, open-label studies L. Anttila1 , M. Kunz2 , J. Marr2 . 1 The Family Federation of Finland, Turku Clinic, 2 Bayer Schering Pharma AG Objectives: To determine the contraceptive efficacy of a combined oral contraceptive (COC) containing ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg administered in a 24/4 regimen (24 active tablets and 4 inert tablets per cycle; YAZ® ), based on a pooled analysis of four, phase III studies. Materials and Methods: A total of 2386 healthy women aged 18– 35 years requesting contraception were included in four, openlabel studies; two randomized, comparative studies and two noncomparative studies. The duration of the studies ranged between 7 and 13 cycles. Contraceptive efficacy was determined using the Pearl Index (PI) and the cumulative probability of pregnancy. Results: A total of 16 pregnancies occurred during 729,537 days’ treatment exposure resulting in a PI of 0.80 (upper limit of the 95% CI: 1.30). Of these pregnancies, 7 were attributed to compliance issues during a treatment exposure time of 616,607 days, resulting in an adjusted PI of 0.41 (upper limit of the 95% CI: 0.85). The cumulative 1-year pregnancy rate was 0.0079 (95% CI: 0.0048; 0.0129). Conclusion: The low-dose COC containing EE 20 mcg/drsp 3 mg administered in 24/4 regimen provides excellent contraceptive efficacy. P736 Contraceptive consciousness among Polish population at the beginning of 21st century R. Matusiak1 , I. Szymusik1 , K. Kosinska-Kaczynska1 , K. Matusiak2 , E. Horosz1 . 1 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland, 2 Students’ Research Group at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland Objective: The aim of the study was to assess the knowledge of contraceptive methods(CM) among Polish population. Material and Methods: The study was carried out on the basis of authors’ inquiry among 185 women (W; aged 14–64; mean 30.51±10.3) and 150 men (M; aged 15–61, mean 29.26±8.6). It consisted of 18 questions concerning sexual life and CM. The majority of respondents came from the cities and were of university or high school education. Results: The majority of respondents were sexually active (W 78%; M 87%) and most of them used contraception (W 68%; M 74%). Condoms are the most common CM among men (56%). Oral ontraception (OC) is most frequently used by females (34%). However, male respondents significantly more often choose coitus interruptus as CM (12% vs 0.5%W; p < 0.05). Women usually gain information about CM from their doctors (67%) and magazines (41%). The most common sources for men are: internet (42%), magazines (37%) and TV (28%). Only 14%W and 11%M know about contraceptive implants. Every fifth men has heard about injectable CM. 70% of respondents want to know more about CM, especially the less frequently used ones. OC is regarded as most effective by 48% W and 28% M (p < 0.05). However, only 5% W consider condoms effective in comparison to 24% M (p < 0.05). Efficacy and lack of side effects are the most important characteristics of CM for all the respondents. Female respondents significantly more often pay attention the cost (11% vs 5%; p < 0.05). Conclusions: The knowledge of CM is satisfactory among Polish population. At the same time there is a need of constant education about all the existing methods. Health care in Poland should