Check Birth Control Start After Ulipristal Acetate
EXECUTIVE SUMMARY
The labeling for ulipristal acetate now contains language that advises patients using the drug for emergency contraception wait five days after the episode of unprotected intercourse before starting a hormonal contraceptive method.
- In a study of taking a progestin-only contraceptive pill the day after ulipristal acetate intake, data suggest that it significantly increased the chance of ovulation within five days.
- Changing the start of the five-day waiting period from the day that ulipristal acetate is taken to the day that unprotected sex occurred offers more flexibility for patients to schedule their follow-up contraception appointment.
- The U.S. Selected Practice Recommendations for Contraceptive Use recommends that when using ulipristal acetate as emergency contraception, patients should wait five days before beginning a new contraceptive method, except for depot medroxyprogesterone acetate shots, the contraceptive implant, and intrauterine contraception, which can be considered for same-day use.
What is your practice of starting a hormonal birth control method after a patient uses ulipristal acetate (ella) for emergency contraception? Clinicians must be aware that the drug’s labeling now recommends that patients using the drug wait five days after the episode of unprotected intercourse before starting a hormonal contraceptive method.
The American Society for Emergency Contraception, a nonprofit advocacy group, has issued guidance to help clinicians. (Access it at: http://bit.ly/1TLN6AN.) Kelly Cleland, MPA, MPH, the organization’s executive director, says the move was prompted by many questions from healthcare providers about how to implement the March 2015 changes in the ella label.
The labeling change was enacted after publication of research indicating initiating a specific type of progestin-only pill (desogestrel, not available in the United States) could counteract the ovulation-suppressing effects of the drug. The study’s authors examined the pharmacodynamic interaction between 30 mg of ulipristal acetate for emergency contraception and 75 mg of desogestrel initiated the next day. Study data indicated that desogestrel impaired the ability of ulipristal acetate to delay ovulation; however, ulipristal acetate produced little effect on the onset of contraceptive effects due to desogestrel.1
By taking the progestin-only pill the day after ulipristal acetate intake, data suggested that it significantly increased the chance of ovulation within five days. In the crossover study, women with imminent ovulation (defined as presenting with a lead follicle measuring between 14-16 mm) took ulipristal acetate or a placebo and then started either a placebo pill or a desogestrel pill the next day. Among cycles in which women started a placebo pill the day after taking the emergency contraception, ovulation occurred within five days in one of 29 cycles. However, when women started the desogestrel pill, ovulation occurred within five days in 13 of 29 cycles.1
Although the study authors only examined one type of hormonal contraception — one that is not available in the United States — these findings suggest that this effect may apply more broadly.
Weigh the Evidence
As the American Society for Emergency Contraception fact sheet highlights, there are many unanswered questions about the potential interaction between progestins and antiprogestins, Cleland notes. The questions include whether this effect applies to all hormonal contraceptives as well as how to best weigh the competing risks of a potential reduction in efficacy of ulipristal acetate vs. the risk of future pregnancy if an ongoing method is not initiated after emergency contraception, she says.
“We hope that new research will clarify some of the areas of uncertainty,” Cleland says.
Until such research emerges, how should clinicians proceed? In the latest edition of the U.S. Selected Practice Recommendations for Contraceptive Use, it is now recommended that when using ulipristal acetate as emergency contraception, patients should wait five days from the date of unprotected intercourse before beginning a new contraceptive method, except for depot medroxyprogesterone acetate shots, the contraceptive implant, and intrauterine contraception, which can be considered for same-day use.3 Advise patients to not engage in intercourse or to use barrier contraception for the next seven days after starting or resuming regular contraception or until her next menses, whichever happens first.
Remember that the copper intrauterine device (ParaGard IUD) is the most effective at preventing pregnancy after unprotected sex. The copper IUD is more effective than either levonorgestrel or ulipristal acetate. Also, it is effective for up to five days after unprotected sex and can be used for ongoing long-term contraception. (Read more about the long-acting reversible contraceptive; see the December 2016 Contraceptive Technology Update article, “Emergency Contraception & LARC - What You Need to Know,” available at: http://bit.ly/2n1lhMV.)
For patients using ulipristal acetate emergency contraception and starting a hormonal contraceptive, the American Society for Emergency Contraception fact sheet recommends starting the five-day period of delay when unprotected sex occurred — before use of the emergency contraception, rather than when the emergency contraceptive is taken.
“This approach may maximize scheduling flexibility while minimizing potential compromise of UPA [ulipristal acetate] efficacy,” the fact sheet states. “However, if it is difficult to accurately determine the date of intercourse, it may be best to start the delay period at EC [emergency contraceptive] intake.”
REFERENCES
- Brache V, Cochon L, Duijkers IJ, et al. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod 2015;30:2785-2793.
- Gould JE, Overstreet JW, Hanson FW. Assessment of human sperm function after recovery from the female reproductive tract. Biol Reprod 1984;31:888-894.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65:1-66.
Results of recent study lead manufacturer of important drug to update its recommendations.
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