Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial.
BACKGROUND
This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen.


METHODS
Three hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl index, adverse event (AE) incidence and bleeding profiles were assessed.


RESULTS
No pregnancies occurred with the continuous oral contraceptive (OC) (Pearl index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months).


CONCLUSIONS
Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.
Teichmann
Alexander
A
Frauenklinik, Klinikum Aschaffenburg, 63739 Aschaffenburg, Germany.
Apter
Dan
D
Emerich
Janusz
J
Greven
Klaus
K
Klasa-Mazurkiewicz
Dagmara
D
Melis
Giambi B
GB
Spaczynski
Marek
M
Grubb
Gary S
GS
Constantine
Ginger D
GD
Spielmann
Daniele
D
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects*; D008137:Longitudinal Studies; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D018579:Patient Selection; D049168:Pregnancy, Unplanned; D018709:Statistics, Nonparametric
D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; D016912:Levonorgestrel