Data showing that Liletta (Allergan/Medicines360), a 52-mg levonorgestrel-releasing intrauterine device (IUD), was highly effective in preventing pregnancy out to 5 years in slim to obese American women with or without children have just been reported.
Liletta "was brought to market at a $50 price for public sector clinics," to address financial barriers that might prevent women from obtaining a long-acting reversible contraceptive, note Stephanie B. Teal, MD, MPH, University of California, Davis and colleagues, in the study published in the January issue of Obstetrics & Gynecology.
They point out that discontinuation rates for infectious or systemic hormonal adverse events with the intrauterine system (IUS) were low. At 5 years, 42% of the women had amenorrhea — defined as no menstrual bleeding or spotting in the previous 90 days — and only 39 women (2.2%) had the device explanted because of bleeding symptoms.
Based on these current results from a large ongoing phase 3 trial — a Comprehensive Contraceptive Efficacy and Safety Study of an IUS (ACCESS IUS) — the US Food and Drug Administration (FDA) approved the device for pregnancy prevention for up to 5 years in October.
In 2015 and 2017, the agency had approved the device for 3 years and 4 years, respectively, supported by earlier findings from ACCESS IUS.
"The study population, which includes approximately 58% nulliparous females, provides important information about safety and efficacy of a hormonal IUS in a typical population of US females," note Teal and colleagues.
The ongoing trial will examine 10 years of continuous use.
Long-Acting Reversible Contraceptive Is Good Option
Almost half (45%) of pregnancies each year in the United States are unintended, Teal and colleagues write, but those using long-acting reversible contraceptive methods have substantially lower rates of unintended pregnancy than those using other methods of reversible contraception.
As previously reported, long-acting reversible contraception methods include a subdermal implant, which can last for 4 years; levonorgestrel IUDs, such as Kyleena, Mirena, and Skyla (Bayer); and the nonhormonal copper IUD ParaGard (CooperSurgical) — all of which can last 6 years.
Yet, the individual cost for contraception is a significant public health concern because socioeconomic level has an important relationship to unintended pregnancy. For example, in 2011, women with household incomes below 200% of the federal poverty level had a 5.6-fold greater risk of unintended pregnancy than those with higher incomes, the researchers explain.
To address these cost barriers, Medicines360, a nonprofit pharmaceutical company, developed Liletta.
The product, which is comarketed by Allergan, is commercially available in the United States, as well as through Medicines360's program to make it available at a lower cost to public health clinics enrolled in the Federal 340B Drug Pricing Program.
The ACCESS IUS study began in 2009 and enrolled 1600 women who were 16 to 35 years old and 151 women who were 36 to 45 years old at 29 sites in the United States. Participants were sexually active, had regular menstrual cycles, were nulliparous or parous, and desired contraception.
The device was successfully implanted in 1568 of the younger women and 146 of the older women.
More than half were nulliparous and a quarter were obese.
In the current analysis, 403 younger women and 92 older women had the device for 5 years, and of these, 176 women were in the 7th year of IUS use.
In 5 years, there were nine pregnancies (four in nulliparous women and five in parous participants), including six ectopic pregnancies, for an ectopic pregnancy rate of 0.13 per 100 woman-years.
The younger women were significantly more likely to report new or worsening acne, dyspareunia, pelvic pain, and dysmenorrhea, whereas the older women were more likely to report weight gain.
The researchers say this indicates that "further assessments of adverse event rates in hormonal IUS users should include evaluation of outcomes by age."
Overall, 1041 (66%) of the 16 to 35 year olds and 69 (47%) of the 36 to 45 year olds withdrew from the study by 5 years, mostly because of an adverse event (18% and 19%, respectively) or wanting to become pregnant (15% and 3%, respectively).
The most common adverse event leading to study discontinuation was expulsion of the device, which occurred in 65 women (3.8%).
Seventy-eight women (4.5%) were diagnosed with ovarian cysts, of whom six women (0.3%) requested removal of the IUS.
And 14 women (0.8%) had a pelvic infection, of whom two (0.1%) had the device removed.
Apart from the ectopic pregnancies, there was only one (0.06%) other serious adverse event, an ovarian cyst that required surgical removal.
"Use of the same product for a longer period of time would allow for fewer [explant and implant] procedures," according to the authors, "which will both decrease healthcare costs and result in less discomfort and risk for females to endure."
As well as the recently approved extended duration of use, the device now has a single-handed inserter, Medicines360 notes.
Principal investigator of the ACCESS IUS study Thomas Kimble, MD, associate dean, assistant professor of obstetrics and gynecology, Eastern Virginia Medical School, Norfolk, said in a company press release: "I can confidently recommend Liletta as a rigorously tested choice for patients who want long-term reversible birth control."
"The fact that it is now indicated for up to 5 years, instead of 4, offers my patients the flexibility of use for either long- or short-term contraception."
The study was designed, overseen, and funded by Medicines360, who also provided the IUS. Teal has served on an advisory board for Merck and her university department receives contraceptive research funding from Bayer HealthCare, Medicines360, Merck, and Sebela. Financial disclosures for the other authors are listed with the article.
Obstet Gynecol. 2019;133:63-70. Abstract
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Cite this: Cheap IUD Is Safe, Effective Contraception Out to 5 Years - Medscape - Jan 02, 2019.