Efficacy and Safety of a Low-Dose 21-Day Combined Oral Contraceptive Containing Ethinylestradiol 20μg and Drospirenone 3mg
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Objective: The purpose of this study was to assess the efficacy and safety of a new low-dose oral contraceptive containing ethinylestradiol 20μg and drospirenone 3mg (EE 20μg/drsp 3mg).
Methods: This was an open-label, non-comparative, multicentre study conducted at 33 centres in Germany and Switzerland. The combined contraceptive was administered over 26 cycles of treatment, with each cycle consisting of once-daily treatment for 21 consecutive days followed by a 7-day hormone-free interval.
Results: A total of 527 women were randomised, of whom 516 (97.9%) started treatment and had at least one study observation. Two pregnancies occurred during 11 165 cycles of treatment, giving a Pearl Index of 0.23 (upper limit of 97.5% CI 0.84). The corresponding 2-year cumulative pregnancy rate was 0.44% (95% CIs 0, 1.05). One of the two pregnancies was attributed to non-compliance with treatment, giving an adjusted Pearl Index of 0.12 (upper limit of 97.5% CI 0.67) over 10 827 compliant cycles. Only three (0.6%) women discontinued treatment because of bleeding problems in this long-term study, suggesting an acceptable bleeding profile. Overall, the study drug was well tolerated and adverse events experienced were typical of hormonal contraceptive use. The majority of women who responded (435 of 501; 86.8%) were satisfied or very satisfied with the study treatment and most (367 of 501; 73.3%) would continue with it if given the choice.
Conclusion: The EE 20μg/drsp 3 mg combined oral contraceptive is an effective and well tolerated contraceptive with an acceptable bleeding pattern.
KeywordsCombine Oral Contraceptive Contraceptive Efficacy Drospirenone Withdrawal Bleeding Normal Menstruation
The authors would like to thank Dr Michael Kunz and Dietmar Trummer (study biometricians), and Andrea Schneider and Richard Glover for their editorial assistance. Funding for this study (protocol number 303860) was provided by Schering AG, Berlin, Germany.
Drs Alincic and Marr are employees of Schering AG, Berlin, Germany. The other authors have no potential conflicts of interest that are directly relevant to the contents of this study.
- 1.Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, editors. Contraceptive technology. 17th revised ed. New York (NY): Ardent Media Inc., 1998: 779–844Google Scholar
- 2.Shvarts S, Besinque K, Atkinson R, et al. New advances in contraception. J Continuing Education 2002; 11-22Google Scholar
- 15.Archer DF, Maheux R, DelConte A, et al. Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 microg levonorgestrel and 20 microg ethinyl estradiol (Alesse). North American Levonorgestrel Study Group (NALSG). Am J Obstet Gynecol 1999 Nov; 181(5 Pt 2): 39–44PubMedCrossRefGoogle Scholar
- 16.Akerlund M, Rode A, Westergaard J. Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. Br J Obstet Gynaecol 1993 Sep; 100(9): 832–8PubMedCrossRefGoogle Scholar
- 19.Endrikat J, Jaques MA, Mayerhofer M, et al. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control and tolerance. Contraception 1995 Oct; 52(4): 229–35PubMedCrossRefGoogle Scholar
- 23.Endrikat J, Muller U, Dusterberg B. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 30 micrograms ethinylestradiol/75 micrograms gestodene, with respect to efficacy, cycle control, and tolerance. Contraception 1997 Mar; 55(3): 131–7PubMedCrossRefGoogle Scholar
- 24.Endrikat J, Cronin M, Gerlinger C, et al. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 75 microg gestodene and a 21-day regimen with 20 microg ethinyl estradiol and 150 microg desogestrel. Contraception 2001 Sep; 64(3): 201–7PubMedCrossRefGoogle Scholar