The FINANCIAL — Actavis plc and Medicines360, a nonprofit women’s health pharmaceutical company, announced that the initial results of ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) were published online on April 28 in the medical journal Contraception.
The study found that LILETTA (levonorgestrel-releasing intrauterine system) 52 mg, is 99.45% effective for the prevention of pregnancy for up to three years of use in women aged 16-35 regardless of race, parity (previous births), or body mass index (BMI). The ACCESS IUS trial is still ongoing and will evaluate the efficacy and safety of LILETTA for up to seven years of use, according to Actavis.
“The rate of unintended pregnancy in the U.S. remains unacceptably high at more than 50% and is even higher amongst women with lower incomes. Only a small percentage of contracepting women (7.7%) are using IUDs which are among the most effective methods. Importantly, not all women have been able to access IUDs due to lack of awareness and cost barriers,” said Mitchell Creinin, MD, Professor and Director of Family Planning in the Department of Obstetrics and Gynecology at the University of California, Davis and senior author of the published study report.
The multicenter clinical trial was conducted by Medicines360 and is the first and only FDA-approval study for an IUD conducted exclusively in the U.S. ACCESS IUS was performed at 29 sites including public health clinics, private offices and University centers The study enrolled 1,751 women aged 16-45, including nearly 60% who had not previously given birth (nulliparous), the largest group of such women ever included in an IUD approval study. Demographics mirrored the 2010 U.S. census; most women were Caucasian (78.4%) or Black/African American (13.3%), and 14.7% were of Hispanic ethnicity. The study had no upper BMI limit for enrollment and 25% of participants were obese.
The primary study outcome was pregnancy rate in women aged 16-35 years. Pregnancies occurred in two nulliparous (never given birth) and four parous (previously given birth) participants. The pregnancy rate (measured as a Pearl Index) for LILETTA was 0.15 (95% CI 0.02, 0.55) per 100-women years during year one and 0.22 (95% CI 0.08, 0.49) per 100-women years through year three. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24, 1.23) through 3 years.
The most common adverse events leading to discontinuation were expulsion (3.5%), bleeding complaints (1.5%), acne (1.3%) and mood swings (1.3%). Most expulsions occurred in the first year, consistent with expulsion timing seen with other IUDs. Of the 68 women followed for fertility after LILETTA discontinuation, 48 (70.6%) conceived spontaneously within six months and 59 (86.8%) within 12 months; the median time to conception was four months.
“ACCESS IUS underscores the importance of increasing our knowledge of the benefits of IUDs and for expanding access to one of the most effective, reversible and well-tolerated forms of birth control for women,” said Kathleen Reape, MD, Senior Vice President, Clinical Development, Global Brands R&D, Actavis. “With our partner Medicines360, we’re proud to make newly-launched LILETTA accessible to all IUD-appropriate women through their health care provider, including public health clinics enrolled in the 340B Drug Pricing Program. Now, more women will have more choices for highly effective contraception.”
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