A comparison of cycle control with monophasic levonorgestrel/ethinylestradiol 100 micrograms/20 micrograms versus triphasic norethindrone/ethinylestradiol 500-750-1000 micrograms/35 micrograms: a multicenter, randomized, open-label study.
OBJECTIVE
This multicenter, randomized, open-label study was undertaken to compare the effects on menstrual cycle control of two oral contraceptive regimens: monophasic levonorgestrel (LNG) 100 micrograms/ethinylestradiol (EE) 20 micrograms (Alesse or Loette) and triphasic norethindrone (NET) 500-750-1000 micrograms/EE 35 micrograms (OrthoNovum 7/7/7).


METHODS
Healthy women with normal menstrual cycles were enrolled and completed up to four cycles of study medication. A total of 384 cycles in the LNG/EE group and 400 cycles in the NET/EE group were evaluable for analysis of cycle control.


RESULTS
For all treatment cycles, the percentage of cycles classified as normal was consistently higher in the LNG/EE group than in the NET/EE group. By cycle 4, 69.9% of cycles with LNG/EE and 54.4% with NET/EE (p < 0.05) were normal. In individual cycles, consistently lower occurrences of intermenstrual bleeding (total bleeding and/or spotting) were seen for the LNG/EE group, although these differences were not statistically significant. Withdrawal bleeding characteristics were comparable between the two groups, except for the length of the latent period, which was significantly longer in the LNG/EE group. The incidence of treatment-emergent adverse events was similar in the two groups.


CONCLUSIONS
This study indicates that the monophasic LNG/EE 100 micrograms/20 micrograms provides better cycle control than the multiphasic NET/EE product, despite its lower EE dose.
Chavez
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A
Baylor College of Medicine, and Research for Health, Houston, Texas, USA.
DelConte
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A
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000494:pharmacology*; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage / Q000494:pharmacology*; D004334:Drug Administration Schedule; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage / Q000494:pharmacology*; D008597:Menstrual Cycle / Q000187:drug effects*; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000494:pharmacology*; D014592:Uterine Hemorrhage / Q000453:epidemiology
D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; D009640:Norethindrone