The Experts below are selected from a list of 210 Experts worldwide ranked by ideXlab platform
Lesley J. Scott - One of the best experts on this subject based on the ideXlab platform.
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Estradiol Valerate/Dienogest
Drugs, 2009Co-Authors: Lesley J. ScottAbstract:▴ Estradiol valerate/dienogest is an oral contraceptive for women that combines the natural estrogen estradiol with the 19-nortestosterone derivative dienogest in a four-phasic formulation. ▴ Estradiol valerate/dienogest demonstrated contraceptive efficacy in a large (n=1377), non-comparative, multicentre study in women aged 18–50 years, with 13 pregnancies over 1797.5 women-years of exposure generating an unadjusted Pearl Index (PI) of 0.73 (upper limit of 95% CI 1.24) [primary endpoint]. Six of the pregnancies were attributed to method failure, resulting in an adjusted PI, based on 1786.5 women-years of exposure, of 0.34 (upper limit of 95% CI 0.73). ▴ In a double-blind study in 798 women aged 18–50 years, estradiol valerate/dienogest and ethinylestradiol/levonorgestrel demonstrated an acceptable bleeding pattern and level of cycle control, according to several co-primary endpoints. ▴ As reported in the UK manufacturer’s summary of product characteristics, the unadjusted PI for women aged 18–35 years or 18–50 years in a pooled analysis of clinical studies was 1.01 (upper limit of 95% CI 1.59) and 0.79 (upper limit of 95% CI 1.23). This pooled analysis of three studies excluded those pregnancies occurring within 14 days of the cessation of therapy. ▴ Estradiol valerate/dienogest was generally well tolerated in this population, with the nature of adverse events generally similar across the studies and between estradiol valerate/dienogest and ethinylestradiol/levonorgestrel.
Monique P. Curran - One of the best experts on this subject based on the ideXlab platform.
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Low-Dose Ethinylestradiol/Levonorgestrel
Drugs, 2005Co-Authors: Toni M. Dando, Monique P. CurranAbstract:▴ Low-dose ethinylestradiol/levonorgestrel 20μg/ 100μg is a combined oral contraceptive that prevents pregnancy primarily by inhibiting ovulation. ▴ The Pearl Index (pregnancies per 100 woman-years of use) with ethinylestradiol/levonorgestrel 20μg/ 100μg was 0.88 and the cumulative pregnancy rate was 1.9% at the end of a 3-year open-label trial (1708 women with 26 554 evaluable cycles). The contraceptive efficacy of ethinylestradiol/levonorgestrel 20μg/100μg was similar to that of other low-dose combined oral contraceptives containing ethinylestradiol 20 or 35μg in a 6-cycle trial (463 evaluable women). ▴ Ethinylestradiol/levonorgestrel 20μg/100μg is well tolerated; adverse events were those commonly associated with combined oral contraceptives. Headache and metrorrhagia (2% of women) were the most common adverse events leading to treatment discontinuation in the 3-year trial. ▴ Cycle control in open-label trials in women receiving up to 36 cycles of ethinylestradiol/levonorgestrel 20μg/100μg was generally good, with the incidence of intermenstrual bleeding being highest during the first few cycles of use and decreasing thereafter.
Daniele Spielmann - One of the best experts on this subject based on the ideXlab platform.
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Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial☆
Contraception, 2009Co-Authors: Alexander T. Teichmann, Dan Apter, Janusz Emerich, Klaus Greven, Klasa-mazurkiewicz D, Giambi B. Melis, Marek Spaczyński, Gary Sondermann Grubb, Ginger D. Constantine, Daniele SpielmannAbstract:Abstract Background This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen. Study Design Three hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl Index, adverse event (AE) incidence and bleeding profiles were assessed. Results No pregnancies occurred with the continuous oral contraceptive (OC) (Pearl Index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months). Conclusions Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.
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Original research article Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial ☆
2009Co-Authors: Alexander T. Teichmann, Dan Apter, Janusz Emerich, Klaus Greven, Klasa-mazurkiewicz D, Giambi B. Melis, Marek Spaczyński, Gary Sondermann Grubb, Ginger D. Constantine, Daniele SpielmannAbstract:Background: This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen. Study Design: Three hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl Index, adverse event (AE) incidence and bleeding profiles were assessed. Results: No pregnancies occurred with the continuous oral contraceptive (OC) (Pearl Index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months). Conclusions: Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.
Raoul Scherwitzl - One of the best experts on this subject based on the ideXlab platform.
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perfect use and typical use Pearl Index of a contraceptive mobile app
Contraception, 2017Co-Authors: Berglund E Scherwitzl, O Lundberg, Kopp H Kallner, Gemzell K Danielsson, James Trussell, Raoul ScherwitzlAbstract:Abstract Objectives The Natural Cycles application is a fertility awareness-based contraceptive method that uses dates of menstruation and basal body temperature to inform couples whether protected intercourse is needed to prevent pregnancies. Our purpose with this study is to investigate the contraceptive efficacy of the mobile application by evaluating the perfect- and typical-use Pearl Index. Study design In this prospective observational study, 22,785 users of the application logged a total of 18,548 woman-years of data into the application. We used these data to calculate typical- and perfect-use Pearl Indexes, as well as 13-cycle pregnancy rates using life-table analysis. Results We found a typical-use Pearl Index of 6.9 pregnancies per 100 woman-years [95% confidence interval (CI): 6.5–7.2], corrected to 6.8 (95% CI: 6.4–7.2) when truncating users after 12 months. We estimated a 13-cycle typical-use failure rate of 8.3% (95% CI: 7.8–8.9). We found that the perfect-use Pearl Index was 1.0 pregnancy per 100 woman-years (95% CI: 0.5–1.5). Finally, we estimated that the rate of pregnancies from cycles where the application erroneously flagged a fertile day as infertile was 0.5 (95% CI: 0.4–0.7) per 100 woman-years. We estimated a discontinuation rate over 12 months of 54%. Conclusions This study shows that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness-based methods. The application may contribute to reducing the unmet need for contraception. Implications The measured typical- and perfect-use efficacies of the mobile application Natural Cycles are important parameters for women considering their contraceptive options as well as for the clinicians advising them. The large available data set in this paper allows for future studies on acceptability, for example, by studying the efficacy for different cohorts and geographic regions.
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Fertility awareness-based mobile application for contraception
The European Journal of Contraception & Reproductive Health Care, 2016Co-Authors: Elina Berglund Scherwitzl, Kristina Gemzell Danielsson, Jonas A. Sellberg, Raoul ScherwitzlAbstract:AbstractObjectives: The aim of the study was to retrospectively evaluate the effectiveness of a fertility awareness-based method supported by a mobile-based application to prevent unwanted pregnancies as a method of natural birth control. Methods: In a retrospective analysis, the application’s efficiency as a contraceptive method was examined on data from 4054 women who used the application as contraception for a total of 2085 woman-years. Results: The number of identified unplanned pregnancies was 143 during 2053 woman-years, giving a Pearl Index of 7.0 for typical use. Ten of the pregnancies were due to the application falsely attributing a safe day within the fertile window, producing a perfect-use Pearl Index of 0.5. Calculating the cumulative pregnancy probability by life-table analysis resulted in a pregnancy rate of 7.5% per year (95% confidence interval 5.9%, 9.1% per year). Conclusions: The application appears to improve the effectiveness of fertility awareness-based methods and can be used to pr...
Toni M. Dando - One of the best experts on this subject based on the ideXlab platform.
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Low-Dose Ethinylestradiol/Levonorgestrel
Drugs, 2005Co-Authors: Toni M. Dando, Monique P. CurranAbstract:▴ Low-dose ethinylestradiol/levonorgestrel 20μg/ 100μg is a combined oral contraceptive that prevents pregnancy primarily by inhibiting ovulation. ▴ The Pearl Index (pregnancies per 100 woman-years of use) with ethinylestradiol/levonorgestrel 20μg/ 100μg was 0.88 and the cumulative pregnancy rate was 1.9% at the end of a 3-year open-label trial (1708 women with 26 554 evaluable cycles). The contraceptive efficacy of ethinylestradiol/levonorgestrel 20μg/100μg was similar to that of other low-dose combined oral contraceptives containing ethinylestradiol 20 or 35μg in a 6-cycle trial (463 evaluable women). ▴ Ethinylestradiol/levonorgestrel 20μg/100μg is well tolerated; adverse events were those commonly associated with combined oral contraceptives. Headache and metrorrhagia (2% of women) were the most common adverse events leading to treatment discontinuation in the 3-year trial. ▴ Cycle control in open-label trials in women receiving up to 36 cycles of ethinylestradiol/levonorgestrel 20μg/100μg was generally good, with the incidence of intermenstrual bleeding being highest during the first few cycles of use and decreasing thereafter.