Long-term safety of an extended-cycle oral contraceptive (Seasonale): a 2-year multicenter open-label extension trial.

Abstract

OBJECTIVE:

The purpose of this study was to assess the long-term safety of Seasonale, 91-day extended-cycle oral contraceptive (OC).

STUDY DESIGN:

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.

CONCLUSION:

This study confirms the findings from the previous clinical trial and demonstrates that Seasonale is a safe and effective therapy for long-term use.

• Authors: F D Anderson, William Gibbons, David Portman
• Journal: American journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 195 Issue 1 Pg. 92-6 (Jul 2006) ISSN: 1097-6868 [Electronic] United States
• PMID: 16813747 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Contraceptives, Oral, Combined
• Seasonale
• Ethinyl Estradiol-Norgestrel Combination

Topics

• Adult
• Contraceptives, Oral, Combined (administration & dosage, adverse effects)
• Ethinyl Estradiol-Norgestrel Combination (administration & dosage, adverse effects)
• Female
• Humans
• Menstruation (drug effects)