Use counseling tips for continuous-use pill

Your next patient says she is interested in using Lybrel, the new continuous-use oral contraceptive (OC). What should you tell her about this form of birth control?

In many ways, Lybrel is no different from other combined oral contraceptives, says Anne Davis, MD, MPH, FACOG, assistant professor of clinical obstetrics and gynecology at Columbia Presbyterian Medical Center in New York City. It contains the same estrogen and progestin as similar low-dose OCs, and it comes in a monthly dispenser.

"What is different about it is the way you take it, not what is in it," says Davis. "There is no scheduled withdrawal bleeding with placebo pills; there is the same pill, every day, and you take one pill every day until you don't need it any more."

The advantage of having an inactive endometrium is the suppression of menses for women with dysmenorrhea or menorrhagia, points out Julia Johnson, MD, professor and vice chair of gynecology in the Division of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology at the University of Vermont College of Medicine in Burlington. The disadvantage of the lack of endometrial development? Unpredictable spotting and bleeding, says Johnson, who has participated in research of the drug.

"Although the majority of women find that the bleeding resolves with continued use of a daily oral contraceptive, it is important for women to be aware of this side effect," says Johnson. "The bleeding and spotting is not a sign of a serious adverse event, but this can be bothersome to women and is a most common reason to stop this form of contraceptive."

While breakthrough bleeding and spotting on Lybrel may decrease over time, some women will continue to have such episodes. One-fifth (21%) of women in the clinical trial had uterine bleeding by Pill Pack 13, with a median of four days of bleeding and three days of spotting per 28-day pill pack. More than three-quarters (77%) of women who experienced bleeding on Pill Pack 13 reported they were satisfied with the method, with 7% as neutral and 16% as dissatisfied.¹

"If women are counseled regarding this side effect, they can often tolerate the bleeding and spotting as an expected early effect of this form of contraceptive," observes Johnson.

Weigh the facts

For Davis, who also has participated in Lybrel's research, counseling on unscheduled bleeding is an important component in determining success with the method.

"The pattern of bleeding is completely unpredictable," she notes. "Overall, when you look at the clinical data over time, there was a slight decrease in the amount of bleeding and spotting days over time, but that is as a group."

Some women may bleed a little in the beginning of pill use and will have no bleeding later on, while other women may not experience bleeding at pill initiation, but develop bleeding in subsequent pill packs.

Women who choose Lybrel should be accepting of unscheduled bleeding before they begin the method, says Davis. Counsel on having a minipad available for such bleeding, and also stress that such bleeding does not indicate sign of infection or illness, she notes.

Advise women to continue taking their pills, even when they experience unscheduled bleeding. If the bleeding or spotting lasts for more than seven consecutive days, women should call their health care provider, the drug packaging states.

There is no determination as to who will experience such episodes, notes Davis.

"You can't look at a woman and say you're going to be the one who's going to have it, because you don't know," she says. "There are no predictors."

Reference

1. Archer DF, Jensen JT, Johnson JV, et al. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: Phase 3 study results. Contraception 2006; 74:439-445.