Continuous,daily levonorgestrel/ethinyl estradiol vs. 21-day,cyclic levonorgestrel/ethinyl estradiol: efficacy,safety and bleeding in a randomized,open-label trial |
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| Affiliation: | 1. Frauenklinik, Klinikum Aschaffenburg, 63739 Aschaffenburg, Germany;2. Väestöliitto/The Sexual Health Clinic, FIN-00100 Helsinki, Finland;3. Institute of Obstetric and Gynecology, Medical University of Gdańsk, 80-402 Gdańsk, Poland;4. 30459 Hannover, Germany;5. Department of Obstetrics and Gynecology, University of Cagliari, 09124 Cagliari, Italy;6. Department of Gynaecology, Obstetrics, and Gynaecologic Oncology, Division of Gynaecological Oncology, Poznan University of Medical Sciences, 61-535 Poznan, Poland;7. Research Headquarters, Wyeth Pharmaceuticals, Collegeville, PA 19426, USA;8. Women''s Health, Wyeth Research, 92931 Paris, France;1. Uppsala University, Department of Environmental Toxicology, Centre for Reproductive Biology in Uppsala, Norbyvägen 18A, 752 36 Uppsala, Sweden;2. Umeå University, Department of Chemistry, KBC 6A, Linnaeus väg 6, 901 87 Umeå, Sweden;1. Eastern Oregon Agricultural Research Center, Oregon State University, Union, OR, United States;2. Forestry Sciences Laboratory, Pacific Northwest Research Station, Seattle, WA, United States;1. Oral and Maxillofacial Surgery;2. Department of Oral and Maxillofacial Pathology, School of Dentistry, University of São Paulo, São Paulo, Brazil;3. Department of Oral Surgery, School of Dentistry, University of São Paulo, São Paulo, Brazil |
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| Abstract: | BackgroundThis 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 DesignThree 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.ResultsNo 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).ConclusionsContinuous 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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