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.
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.


METHODS
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 150/30mcg, 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.


CONCLUSIONS
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.
Kashanian
Maryam
M
Department of Obstetrics & Gynecology, Iran University of Medical Sciences, 16117 Tehran, Iran. maryamkashanian@yahoo.com
Shahpourian
Farangis
F
Zare
Omolbanin
O
D000293:Adolescent; D000328:Adult; D001835:Body Weight / Q000187:drug effects; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007492:Iran; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D008796:Metrorrhagia / Q000139:chemically induced; D009325:Nausea / Q000139:chemically induced; D017060:Patient Satisfaction
D003278:Contraceptives, Oral, Hormonal; D004997:Ethinyl Estradiol; D016912:Levonorgestrel