Long-term safety of an extended-cycle oral contraceptive (Seasonale): a 2-year multicenter open-label extension trial.
OBJECTIVE
The purpose of this study was to assess the long-term safety of Seasonale, 91-day extended-cycle oral contraceptive (OC).


METHODS
Following completion of a 1-year Phase 3 multicenter trial, patients from selected centers were invited to participate in this 2-year extension trial. In this open-label study all participants received the 91-day extended-regimen OC, Seasonale.


RESULTS
There were 189 study participants enrolled from 27 sites. Patient exposure included 1130 completed 91-day cycles. Overall rates of study discontinuation and the incidence of adverse events were similar to the earlier Phase 3 clinical trial. Seasonale was well tolerated and the number of reported bleeding and/or spotting days reported diminished during the course of the study.


CONCLUSIONS
This study confirms the findings from the previous clinical trial and demonstrates that Seasonale is a safe and effective therapy for long-term use.
Anderson
F D
FD
Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, VA, USA. fanderson4@cox.net
Gibbons
William
W
Portman
David
D
D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008598:Menstruation / Q000187:drug effects
D003277:Contraceptives, Oral, Combined; C482584:Seasonale; D019304:Ethinyl Estradiol-Norgestrel Combination