Abstract
Objective: To compare the cycle control, efficacy, and safety of a new low-dose combined oral contraceptive containing ethinylestradiol 20μg and drospirenone 3mg with an established formulation containing ethinylestradiol 20μg and desogestrel 150μg.
Methods: This was a randomized, open-label, parallel-group, multicenter study of healthy women (aged 18–35 years) over seven treatment cycles. Both combined oral contraceptives were administered once daily for 21 consecutive days followed by a 7-day hormone-free interval.
Results: A total of 445 women were randomized to treatment; of these, 441 (ethinylestradiol 20μg/drospirenone 3mg, n = 220; ethinylestradiol 20μg/desogestrel 150μg, n = 221) went on to receive study medication. There was a trend towards reduced intracyclic bleeding with continued treatment in both treatment groups, consistent with clinical experience. Intracyclic bleeding was highest during the first treatment cycle in both treatment groups, but was generally much lower in subsequent cycles. More than 90% of women in each of the groups experienced withdrawal bleeding during the study. The duration of withdrawal bleeding remained fairly constant throughout the study. The maximum intensity was mainly bleeding, rather than spotting. Overall, cycle control, efficacy, and safety profiles were comparable between both groups. Adverse events were generally of mild-to-moderate intensity and were those typical of hormonal contraceptive use.
Conclusion: In conclusion, both ethinylestradiol 20μg/drospirenone 3mg and ethinylestradiol 20μg/desogestrel 150μg are effective and well tolerated contraceptives that provide good cycle control.
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References
Hatcher RA, Guillebaud J. The pill: combined oral contraceptives. In: Hatcher RA, Trussell J, Stewart F, editors. Contraceptive technology. 17th rev. ed. New York: Ardent Media Inc., 1998: 405–66
Foidart JM, Wuttke W, Bouw GM, et al. A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel. Eur J Contracept Reprod Health Care 2000 Jun; 5(2): 124–34
Lammers P, op ten Berg M. Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. Acta Obstet Gynecol Scand 1991; 70(6): 497–500
Kirkman RJ, Pedersen JH, Fioretti P, et al. Clinical comparison of two low-dose oral contraceptives, Minulet and Mercilon, in women over 30 years of age. Contraception 1994 Jan; 49(1): 33–46
Archer DF, Maheux R, DelConte A, et al. A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms: North American Levonorgestrel Study Group (NALSG). Contraception 1997 Mar; 55(3): 139–44
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): 39–44
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): 832–8
Endrikat J, Dusterberg B, Ruebig A, et al. Comparison of efficacy, cycle control, and tolerability of two low-dose oral contraceptives in a multicenter clinical study. Contraception 1999 Nov; 60(5): 269–74
An open-label, multicenter, noncomparative safety and efficacy study of Mircette, a low-dose estrogen-progestin oral contraceptive: the Mircette Study Group. Am J Obstet Gynecol 1998 Jul; 179 (1): S2-8
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): 131–7
Huber J, Foidart JM, Wuttke W, et al. Efficacy and tolerability of a monophasic oral contraceptive containing ethinylestradiol and drospirenone. Eur J Contracept Reprod Health Care 2000 Mar; 5(1): 25–34
Bachmann G, Sulak PJ, Sampson-Landers C, et al. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3mg drospirenone. Contraception 2004 Sep; 70(3): 191–8
Apter D, Borsos A, Baumgartner W, et al. Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms. Eur J Contracept Reprod Health Care 2003 Mar; 8(1): 37–51
Borenstein J, Yu HT, Wade S, et al. Effect of an oral contraceptive containing ethinyl estradiol and drospirenone on premenstrual symptomatology and health-related quality of life. J Reprod Med 2003 Feb; 48(2): 79–85
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Gruber, D.M., Huber, J.C., Melis, G.B. et al. A Comparison of the Cycle Control, Safety, and Efficacy Profile of a 21-Day Regimen of Ethinylestradiol 20μg and Drospirenone 3mg with a 21-Day Regimen of Ethinylestradiol 20μg and Desogestrel 150μg. Mol Diag Ther 5, 115–121 (2006). https://doi.org/10.2165/00024677-200605020-00005
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DOI: https://doi.org/10.2165/00024677-200605020-00005