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      Contraceptive efficacy and tolerability of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study

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          Abstract

          Background

          The contraceptive efficacy and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 μg/drospirenone (DRSP) 3 mg to extend the menstrual cycle and enable management of intracyclic (breakthrough) bleeding (flexible MIB) was investigated and the bleeding pattern compared with a conventional 28-day regimen and a fixed extended 124-day regimen.

          Study design

          This Phase III, 2-year, multicentre, open-label study randomly (4:1:1) allocated women (aged 18–35 years) to the following regimens: flexible MIB (24–120 days' active hormonal intake with 4-day tablet-free intervals); conventional (24 days' active hormonal intake followed by a 4-day hormone-free interval); or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval). Primary outcomes included the number of bleeding/spotting days during Year 1 (all regimens) and the number of observed unintended pregnancies over 2 years (flexible MIB only).

          Results

          Results were analysed in 1067 women (full analysis set). The mean number of bleeding/spotting days was lower with the flexible MIB vs the conventional regimen [41.0±29.1 (95% CI 38.8–43.3) vs 65.8±27.0 (95% CI 62.2–69.4) days, p<0.0001; treatment difference −24.8 (95% CI −29.2 to −20.3) days]. The corresponding value for the fixed extended regimen was 60.9±51.1 (95% CI 53.9–67.9) days. The Pearl Index for the flexible MIB regimen was 0.64 (95% CI 0.28–1.26). All regimens had comparable tolerability profiles.

          Conclusions

          EE 20 μg/DRSP 3 mg administered as a flexible extended regimen with MIB is effective, well tolerated and is associated with statistically significantly fewer bleeding/spotting days and fewer withdrawal bleeding episodes vs EE/DRSP in a conventional 28-day regimen. The flexible MIB also provided statistically significantly fewer spotting days vs EE/DRSP in a fixed extended 124-day regimen ( post hoc evaluation). The flexible MIB regimen allows women to extend their menstrual cycle and manage their intracyclic (breakthrough) bleeding.

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          Most cited references21

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          Preferred frequency and characteristics of menstrual bleeding in relation to reproductive status, oral contraceptive use, and hormone replacement therapy use.

          This study addresses attitudes towards changes in menstrual bleeding patterns caused by oral contraceptives (OC) or hormone replacement therapy (HRT) and preferred changes in bleeding pattern with and without use of OC or HRT in relation to reproductive age group. Data were collected by means of telephone interviews with 325 women in each of four age groups (15-19, 25-34, 45-49, and 52-57 years). In total, 80.5% of currently menstruating women preferred one or more changes in bleeding pattern such as less painful, shorter, or less heavy periods, or amenorrhea. The majority of the menstruating women in all age groups preferred to have a bleeding frequency of less than once a month or never, whether the bleeding was spontaneous or induced by OC. In the case of HRT, amenorrhea was most preferred. These findings with respect to preferred bleeding frequency and OC may have important implications for health care providers and for future contraception development.
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            Suppression of ovarian activity with a drospirenone-containing oral contraceptive in a 24/4 regimen.

            This study was conducted to compare ovarian activity of an oral contraceptive containing drospirenone (drsp) 3 mg plus ethinylestradiol (EE) 20 mcg administered in 24/4 regimen compared with the conventional 21/7 regimen, during intended use and following predefined dosing errors. Women aged 18-35 years who ovulated or had a follicular diameter of >or=15 mm on or before Day 23 during a pretreatment cycle were admitted into this double-blind, randomized study. Participants underwent 3 treatment cycles with drsp 3 mg/EE 20 mcg in a 24/4 (n=52) or a 21/7 (n=52) regimen. In the third treatment cycle, the initial three pills in both groups were replaced with placebos. Ovarian activity was classified using the Hoogland scale during pretreatment and during Cycles 2 and 3. Suppression of ovarian activity was more pronounced with the 24/4 regimen--the odds ratio for a lower Hoogland score (i.e., greater ovarian suppression) with the 24/4 regimen compared with the conventional 21/7 regimen were 6.01 (95% CI: 2.29-17.94) and 3.06 (95% CI: 1.44-6.65) for Cycles 2 and 3, respectively. More women in the 24/4 regimen group had no ovarian activity 87.8% vs. 56.0% during Cycle 2 and 55.1% vs. 30.0% during Cycle 3. The 24/4 regimen was associated with a more consistent suppression (less fluctuation) of endogenous estradiol. The drsp 3 mg/EE 20 mcg oral contraceptive in a 24/4 regimen was associated with greater ovarian suppression (despite intentional dosing error), which results in decreased hormonal fluctuations, and may increase contraceptive efficacy with the low-dose formulation.
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              Women's and providers' attitudes toward menstrual suppression with extended use of oral contraceptives.

              The United States Food and Drug Administration approved a dedicated extended regimen of oral contraceptive (OC) pill in the fall of 2003. Few studies have explored how women or providers feel about menstrual suppression. This study describes women's and providers' attitudes toward menstrual suppression. A national sample of 1470 women and 512 providers responded to surveys asking about attitudes toward menstrual suppression. Seventy-eight percent of the women sample had never heard of menstrual suppression with OCs. Fifty-nine percent of women would be interested in not menstruating every month and one third would choose never to have a period. Only 7% of the providers thought it was physically necessary to have a period every month and 44% thought that menstrual suppression is a good idea. While 57% of providers said that their patients do not ask about extended use of OCs, 52% do prescribe them; patient request was the most common reason. Both samples thought that more research should be conducted and that the factors that would influence their decisions included long-term health effects, side effects, future fertility and cost. Results demonstrate that providers need to discuss this option with their patients.
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                Author and article information

                Journal
                J Fam Plann Reprod Health Care
                J Fam Plann Reprod Health Care
                familyplanning
                jfp
                The Journal of Family Planning and Reproductive Health Care
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1471-1893
                2045-2098
                1 April 2012
                1 April 2012
                : 38
                : 2
                : 73-83
                Affiliations
                [1 ]President and Medical Director, Dinox BV, Groningen, The Netherlands
                [2 ]Vice-President and Director Clinical Research,, Dinox BV, Groningen, The Netherlands
                [3 ]Researcher and Gynaecologist, Clinique de Recherche en Santé des Femmes, Québec, Canada
                [4 ]Vice-President Clinical Development, Global Clinical Development, Bayer HealthCare Pharmaceuticals, Berlin, Germany
                [5 ]Principal Statistician, Global Biostatistics, Bayer HealthCare Pharmaceuticals, Berlin, Germany
                [6 ]Global Clinical Leader, Bayer HealthCare Pharmaceuticals, Berlin, Germany
                Author notes
                Correspondence to Dr Jörg Elliesen, Bayer HealthCare Pharmaceuticals, Müllerstrasse 178, D-13353 Berlin, Germany; joerg.elliesen@ 123456bayer.com
                Article
                familyplanning-2011-100213
                10.1136/jfprhc-2011-100213
                3353880
                22454003
                727e6bd0-438a-4504-94bf-6d6cb413386f
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 5 September 2011
                : 10 February 2012
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