Background: One of the most common reversible birth control techniques is the use of oral contraceptives. Although they have been available for more than 40 years, the only change in them has been a gradual reduction in the hormone content. The traditional pill offers a 21-day active component followed by a seven-day hormone-free period.
Several adverse effects (e.g., pelvic pain, breast tenderness, bloating/swelling symptoms) are related to this hormone-free period, as is an increase in the use of pain medications. In addition, the hormone-free period with the lower hormone dose contraceptives has been shown to decrease their effectiveness. Solutions to this have been to shorten the hormone-free period (e.g., three days) or add an estrogen supplement during this time. Another option is a new extended oral contraception regimen that has 84 days of active ingredients followed by seven days of a hormone-free interval. One common adverse effect of this extended contraception is breakthrough bleeding or spotting. Sulak and colleagues measured the bleeding patterns of women using the extended oral contraception and developed management strategies for breakthrough bleeding or spotting.
The Study: The participants in this prospective study were women 18 to 48 years of age who were current oral contraceptive users for at least three months. Before starting the extended oral contraception method, the participants were placed on two cycles of the standard 21/7 oral contraception. The total time on the extended oral contraception was 168 days. Patients were asked to rate their breakthrough bleeding or spotting on a scale of 0 to 4 with specific parameters. The group that had heavier breakthrough bleeding during the 21/7 cycles was compared with the group that had a lighter bleeding pattern.
Women who had seven or more consecutive days of breakthrough bleeding or spotting during the extension phase were randomized into two treatment strategies. With the first, patients were instructed to initiate a three-day hormone-free period, then restart the extended contraception. The second strategy was to encourage the women to continue with the extended regimen for seven more days and, if the bleeding did not resolve, to try a three-day hormone-free period. The main outcome measure was the assessment of breakthrough bleeding or spotting during the extended oral contraception regimen. A secondary outcome was the response to different treatment strategies. Of the 102 women who completed the study, nine stopped the extended regimen; four did so because of adverse effects.
Results: Women who had a heavier daily flow rate during the 21/7 cycle before the extended regimen were significantly more likely to have heavier flow and earlier breakthrough bleeding during the extended regimen. The average daily flow rating during the extended period was 0.21 (on the 0 to 4 scale), which improved over time. Participants who had breakthrough bleeding or spotting for seven consecutive days had a better response to a hormone-free interval than those randomized to the other treatment strategy.
Conclusion: The authors conclude that a 168-day extended oral contraception regimen resulted in an acceptable rate of breakthrough bleeding or spotting and had a high rate of continuation. The best strategy for managing bleeding during the extended cycle was a three-day hormone-free interval.