Options might begin to emerge with new data out on LARC
Time to embrace evidence-based practice as choice options may expand
Executive Summary
The American College of Obstetricians and Gynecologists says that long-acting reversible contraception (LARC) methods are safe, effective, and appropriate options for teens, but some might perceive high discontinuation rates among younger women and therefore steer patients away from them.
-
Data from the St. Louis Contraceptive CHOICE Project indicates that discontinuation rates of LARC methods at six months is low (less than 10%) and is not increased in teens and young women.
-
A new international study looking at the 13.5 mg levonorgestrel IUD plus a 19.5 mg levonorgestrel device in advanced clinical trials suggest both are safe and effective. In the 13.5 mg and 19.5 mg groups, 21.9% and 19.1% discontinued the study over three years, respectively, including 1.0% and 1.2% who stopped due to serious adverse events and 4.7% and 4.9% who left due to menstrual bleeding disturbances.
Progress is being made on the long-acting reversible contraception (LARC) front to promote top-tier effective methods to women.
According to the New York City-based Guttmacher Institute, in 2009, 8.5% of women using contraceptives relied on such LARC methods as the implant (Nexplanon, Merck & Co., Whitehouse Station, NJ) and the intrauterine device (IUD), reflecting a rise from 5.5% in 2007 and 2.4% in 2002.1 Currently U.S.-approved IUDs include ParaGard, Teva Women's Health, North Wales, PA, and Mirena, Bayer HealthCare Pharmaceuticals, Wayne, NJ. Most of the women who use long-acting reversible methods choose IUDs; nearly 8% of women using contraception use the IUD, and less than 1% use the implant.1
With a 2012 American College of Obstetricians and Gynecologists committee opinion stating that long-acting reversible contraceptives such as the IUD and the contraceptive implant are safe, effective, and appropriate options for adolescents.2 (To read more about the opinion, see the Contraceptive Technology Update article, "Long-acting methods safe for teens: include options in your counseling," December 2012, p. 133.) However, some providers might perceive high discontinuation rates among younger women and therefore steer patients away from LARC methods.3
New analysis of data from the St. Louis Contraceptive CHOICE Project should eliminate such a perception. The analysis indicates that rates of discontinuation of LARC methods at six months is low (less than 10%) and not increased in adolescents and young women.2
Discontinuation rates measured
Researchers at the Washington University School of Medicine in St. Louis designed the analysis to measure discontinuation within six months among users of the levonorgestrel intrauterine system, copper IUD, and the etonogestrel implant, and to identify baseline characteristics associated with early discontinuation. They drew data from the project, a cohort study of 9,256 participants provided with no-cost contraception and followed with telephone interviews at three and six months
The analysts used logistic regression to investigate characteristics associated with early discontinuation of the two IUDs and implant and determined reasons for discontinuation. A total of 6,167 participants were eligible for the analysis; follow-up data were available for 5,928 participants. More than 90% (5,495) were using their method at six months and 433 (7%) had discontinued. Discontinuation rates were 7.3%, 8.0%, and 6.9% for the levonorgestrel intrauterine system, copper IUD, and implant, respectively.
After adjusting for age, race, marital status, low socioeconomic status, and history of sexually transmitted infection, analysts found that unmarried women were slightly more likely to discontinue compared with married women (adjusted odds ratio [OR] 1.26, 95% confidence interval [CI] 1.01-1.59 and adjusted OR 1.62, 95% CI 1.11-2.37, respectively). No other baseline characteristics, including younger age (ages 14-19), were associated with early discontinuation. The most common reason given for discontinuation was cramping among IUD users and irregular or frequent bleeding among implant users.3
"Rates of discontinuation of long-acting reversible contraception at six months is low and not increased in adolescents and young women," state the researchers. "Intrauterine devices and the implant should be considered as first-line contraceptive options among all women to reduce unintended pregnancy."
(Interested in getting a LARC program going at your facility? Visit the "LARC First" resource web site, www.larcfirst.com, put together by the Contraceptive CHOICE Project. Get troubleshooting tips on LARC insertions and removals, staff cross-training information, contraceptive counseling scripts, and more.)
New options in research
More patients and providers might be interested in intrauterine contraception with the 2013 advent of Skyla, a new intrauterine system from Bayer HealthCare Pharmaceuticals of Wayne, NJ. The small, flexible plastic T-shaped device contains 13.5 mg levonorgestrel; its body measures 28 mm x 30 mm. The drug is released at an average in vivo rate of approximately 6 mcg/day over three years. It is approved for up to three years of contraceptive use. (To read more above the device, see the CTU article, "FDA approves smaller levonorgestrel intrauterine system — a 'mini-Mirena,'" March 2013, p. 25.)
Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville, said, "I find the smaller LNG IUD a welcome option in my practice, particularly for nulliparous women and others who may have a tighter or less flexible cervix."
A just-published international study looks at both the U.S.-approved 13.5 mg levonorgestrel IUD, as well as a 19.5 mg levonorgestrel device that is now in advanced clinical trials in the United States. Both devices were found to be safe and effective in preventing pregnancies, data suggests.4
To perform the study, researchers enrolled nulliparous and parous women ages 18-35 with regular menstrual cycles who were requesting contraception. Participants were randomized to three years of treatment with one of the two studied levonorgestrel intrauterine contraceptive systems. The primary outcome was the pregnancy rate, calculated as the Pearl Index.
Overall, 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups, respectively, had a placement attempted and were included in the full analysis set to evaluate efficacy and safety. Mean (standard deviation) age was 27.1 (4.8) years; 39.2% were nulliparous. Over the three-year period, 0.33 pregnancies per 100 women-years (95% CI 0.16-0.60) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years (95% CI 0.15-0.57) with the 19.5 mg intrauterine contraceptive system. Kaplan-Meier estimates for that period were 0.009 and 0.010, respectively. Partial expulsions occurred in 4.56% and 3.58% of treatment groups, respectively. Ten of the 20 pregnancies were ectopic. Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation.4
Scientists note that in the 13.5 mg system and 19.5 mg system groups, 21.9% and 19.1% of women discontinued for any adverse event over three years, including 1.0% and 1.2% who discontinued for serious adverse events and 4.7% and 4.9% who discontinued for disturbances in menstrual bleeding, including amenorrhea, respectively. In total, 57% and 60% of women completed three years of treatment with the 13.5 mg system and 19.5 mg system, respectively.4
"By demonstrating the safety and efficacy of low-dose intrauterine contraceptive devices, this study will help expand the contraceptive options available to women who have not had children before," says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles and corresponding author of the study. "Additionally, a lower dose system may be preferable to women who are seeking to reduce their exposure to synthetic hormones."
Don't forget IUD for EC
As more women become aware of the IUD as a LARC option, don't forget to educate on its use as an extremely effective form of emergency contraception (EC).
Planned Parenthood League of Massachusetts (PPLM) in Boston launched its EC4U campaign in November 2013 to educate its patients about EC and raise awareness among women in Massachusetts of the variety of EC options available to them.
All seven PPLM locations across Massachusetts carry the full range of EC options: the copper IUD (ParaGard); levonorgestrel emergency contraceptives pills Plan B One-Step (Teva) and Next Choice (Actavis, Parsippany, NJ); and the ulipristal acetate pill, ella (Actavis).
Staff members at the seven sites educate patients on the benefits of each of these methods. Information about the copper IUD denotes that it is most effective method; it can be used up to five days after unprotected sex and also can be left in place as a highly effective method of contraception for up to 12 years after insertion.
In an announcement of the new program, Marty Walz, president and chief executive officer of the Massachusetts organization, said, "As the state's leading women's healthcare provider and advocate, PPLM is proud to launch EC4U as part of our work to increase access to emergency contraception, reduce unintended pregnancies, and keep women healthy."
REFERENCES
- Finer LB, Jerman J, Kavanaugh ML. Changes in use of long-acting contraceptive methods in the United States, 2007-2009. Fertil Steril 2012; 98(4):893-897.
- Kavanaugh ML, Frohwirth L, Jerman J, et al. Long-acting
- reversible contraception for adolescents and young adults: patient and provider perspectives. J Pediatr Adolesc Gynecol 2013; 26(2):86-95.
- Grunloh DS, Casner T, Secura GM, et al. Characteristics associated with discontinuation of long-acting reversible contraception within the first 6 months of use. Obstet Gynecol 2013; 122(6):1,214-1,221.
- Nelson A, Apter D, Hauck B, et al. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol 2013; 122(6):1,205-1,213.
