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Effects of Oral Contraceptives Containing Ethinylestradiol with Either Drospirenone or Levonorgestrel on Various Parameters Associated with Well-Being in Healthy Women

A Randomized, Single-Blind, Parallel-Group, Multicentre Study

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Abstract

Background: The combined oral contraceptive Yasmin® (drospirenone 3 mg plus ethinylestradiol 30 μg [DRSP 3 mg/EE 30 μg]) has been shown to be a well tolerated and effective combination that provides high contraceptive reliability and good cycle control. Furthermore, DRSP 3 mg/EE 30 μg has been shown to have a positive effect on premenstrual symptoms and well-being/health-related quality of life, and to improve the skin condition of women with acne. To date, however, there have been relatively few studies that have compared the effects of DRSP 3 mg/EE 30 μg on the general well-being of women with those of other oral contraceptives.

Objectives: To compare the impact of DRSP 3 mg/EE 30 μg with that of levonorgestrel 150 mg/EE 30 μg (LNG 150 μg/EE 30 μg; Microgynon® 30) on various parameters associated with well-being in healthy female subjects.

Methods: This was a randomized, single-blind, parallel-group, multicentre study conducted using 21/7-day regimens of DRSP 3 mg/EE 30 μg and LNG 150 μg/EE 30 μg over seven cycles. Efficacy parameters included: changes in Menstrual Distress Questionnaire (MDQ) normative T scores; the proportion of subjects with acne; and menstrual symptoms. Cycle control and subjective well-being parameters were also assessed.

Results: Treatment with DRSP 3 mg/EE 30 μg had similar beneficial effects on symptoms of water retention and impaired concentration to LNG 150 μg/EE 30 μg, but was significantly better in alleviating negative affect symptoms during the menstrual phase (median difference in MDQ T score −3; p = 0.027; Wilcoxon rank sum test). The proportion of subjects with acne decreased from approximately 55% to approximately 45% in the DRSP 3 mg/EE 30 μg group, but remained static at approximately 60% in the LNG 150 μg/EE 30 μg group. Somatic and psychological symptoms occurred at the greatest intensity and for most subjects during the menstrual phase of the cycle in both groups. Both drugs had similar cycle control parameters with a tendency towards reduced bleeding with continued use. More subjects in the DRSP 3 mg/EE 30 μg group reported improved physical well-being (60% vs 46%; p = 0.035; chi-squared [χ2] test). Emotional well-being was reported improved in 61% and 51% of DRSP 3 mg/EE 30 μg and LNG 150 μg/EE 30 μg users, respectively (p = 0.1190; χ2 test). Adverse events were typical of oral contraceptive use and did not give rise to any safety concerns.

Conclusion: Both products had similar beneficial effects on symptoms of water retention and impaired concentration, but DRSP 3 mg/EE 30 μg was significantly better in alleviating negative affect symptoms during the menstrual phase. The proportion of subjects with acne decreased in the DRSP 3 mg/EE 30 μg group but not in the LNG 150 μg/EE 30 μg group. More subjects in the DRSP 3 mg/EE 30 μg group reported improved physical well-being compared with the LNG 150 μg/EE 30 μg group.

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Acknowledgements

Funding for this study was provided by Bayer Schering Pharma AG, Berlin, Germany. Bayer Schering Pharma AG co-ordinated the writing of the manuscript with all authors. All authors approved the final version of the manuscript. Editorial assistance for the development of this manuscript was provided by Richard Glover and Jenny Szkolar, Medical Writers, Wolters Kluwer, with the financial support of Bayer Schering Pharma AG.

Sue Kelly and Rick Carter are former employees of Bayer Schering Pharma (formerly known as Schering Health Care Ltd). Christoph Gerlinger is a full-time employee of Bayer Schering Pharma. Carol McKinnon and Andrew Smithers received pro rata investigator remuneration grants from Bayer Schering Pharma based on the number of patients entering the study. The other authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Connaught Clinical Consulting, Sydney, New South Wales, Australia

    Sue Kelly

  2. Waterfront Medical Centre, Heol-y-Llongau, South Glamorgan, UK

    Emyr Davies

  3. The Burns Practice, Bennetthorpe, Doncaster, UK

    Simon Fearns

  4. Castlemilk Health Centre, Glasgow, UK

    Carol McKinnon

  5. AP Clinical Services Ltd, 85 Albury Road, Merstham, Surrey, RH1 3LP, UK

    Rick Carter

  6. Bayer Schering Pharma AG, Berlin, Germany

    Christoph Gerlinger

  7. Park Leys Medical Practice, Keresley Green, Coventry, UK

    Andrew Smithers

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  1. Sue Kelly
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  2. Emyr Davies
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  3. Simon Fearns
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  4. Carol McKinnon
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  7. Andrew Smithers
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Correspondence to Rick Carter.

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Kelly, S., Davies, E., Fearns, S. et al. Effects of Oral Contraceptives Containing Ethinylestradiol with Either Drospirenone or Levonorgestrel on Various Parameters Associated with Well-Being in Healthy Women. Clin. Drug Investig. 30, 325–336 (2010). https://doi.org/10.2165/11535450-000000000-00000

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  • DOI: https://doi.org/10.2165/11535450-000000000-00000

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