A comparison between monophasic levonorgestrel–ethinyl estradiol 150/30 and triphasic levonorgestrel–ethinyl estradiol 50–75–125/30–40–30 contraceptive pills for side effects and patient satisfaction: A study in Iran Maryam Kashanian a, *, Farangis Shahpourian b , Omolbanin Zare b a Iran University of Medical Sciences, Department of Obstetrics & Gynecology, 16117 Tehran, Iran b Iran University of Medical Sciences, Department of Midwifery, 16117 Tehran, Iran 1. Introduction Combined estrogen–progestogen oral contraceptive pills (OCPs) are amongst the most effective and reliable methods of contraception, used by many women throughout the world [1]. Concerns regarding the metabolic and cardiovascular adverse effects of OCPs resulted in the production of new formulations with the least (but at the same time effective) necessary steroids [2]. In these new formulations the amount of ethinyl estradiol (EE), which is the most common estrogenic agent of OCPs, is about 20–40 mcg [3]. This reduction in the amount of steroids has been used for the progestogenic component also, and new OCPs contain less than 10% of the progestogens of the former pills [1]. Also, the progestogens have been changed in order to reduce side effects [4] and, at the present time, OCPs have less metabolic effect compared to earlier formulations. However, with decreasing amounts of estrogens and progestogens in OCPs, the adverse effects of ‘‘unscheduled bleeding/spotting’’ or breakthrough bleeding/spotting (BTB/S) would increase if their amounts are not enough to maintain endometrial stability [1]. Triphasic pills have been produced in order to decrease the total amount of consumed steroids as much as possible. These pills have three phases which, in every phase, have different amounts of progestogens [5] and in some formulations, the amount of estrogen will be increased during the second phase also. The aims of producing these new pills were to decrease their metabolic side effects and, at the same time, to minimize bleeding problems while preserving their efficacy [6]. In studies that compared monophasic and triphasic pills with each other, their risk/benefit profiles were almost similar [1,6]. Studies have shown that about 50% of pill consumers discontinue pill-taking within 24 months, mostly due to their common side effects [7]. Therefore finding pills with the least adverse effects and thus higher acceptability for women in every society is a necessity [8] in order to decrease the discontinuation European Journal of Obstetrics & Gynecology and Reproductive Biology 150 (2010) 47–51 ARTICLE INFO Article history: Received 4 September 2009 Received in revised form 7 January 2010 Accepted 27 January 2010 Keywords: Oral contraceptive pill Monophasic pill Triphasic pill Ethinyl estradiol Levonorgestrel ABSTRACT Objective: Oral contraceptive pills (OCPs) are one of the most effective reversible and accessible contraceptives, and patient acceptance for their use depends partly on the unfavorable adverse effects. The present study compared the two kinds of OCPs (monophasic; levonorgestrel (LNG)–ethinyl estradiol (EE) 150/30 versus triphasic; LNG–EE 50–75–125/30–40–30) for adverse effects and patient satisfaction. Study design: A randomized clinical trial was performed on 314 women who used OCPs for the first time, as their contraception, for 6 months. Overall, 1884 cycles were studied. In the monophasic group (n = 159 who finally finished the study), monophasic pills LNG–EE 150/30 mcg, and in the triphasic group (n = 155 who finally finished the study), triphasic pills LNG–EE 50–75–125/30–40–30 mcg were used. Statistical analysis was performed using SPSS 10: Chi square test, Fisher exact test and Student’s t-test were used. Results: There were no significant differences between the two groups for common side effects, including nausea, headache, nervousness, facial hyperpigmentation (chloasma), and body weight (increase or decrease) but breakthrough bleeding and spotting (BTB/S) were less in the triphasic group, occurring in 30 cycles (18.86%) versus 10 cycles (6.45%), P = 0.009*. Patient satisfaction for the two OCPs was similar and high. The rates of side effects were low. Conclusion: It seems that the monophasic and triphasic pills are similar according to patient satisfaction and side effects; therefore there is no benefit of one over the other except for BTB/S, for which triphasic is superior. ß 2010 Elsevier Ireland Ltd. All rights reserved. * Corresponding author at: No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue, 16117 Tehran, Iran. Tel.: +98 21 77523487; fax: +98 21 77607016. E-mail address: maryamkashanian@yahoo.com (M. Kashanian). Contents lists available at ScienceDirect European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb 0301-2115/$ – see front matter ß 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ejogrb.2010.01.010