Date: 2015-04-28
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in Contraception
Company: Actavis (Ireland) Medicines360 (USA - CA)
Product: Liletta™ (levonorgestrel-releasing intrauterine system)
Action
mechanism: progestin. Liletta™ is indicated for prevention of pregnancy for up to 3 years. The system should be replaced after 3 years if continued use is desired. Liletta™ contains 52 mg of levonorgestrel. Initially, levonorgestrel is released at a rate of 18.6 mcg/day. This rate decreases progressively to approximately 16.3 mcg/day at 1 year, 14.3 mcg/day at 2 years, and 12.6 mcg/day at 3 years after insertion. The average in vivo release rate of levonorgestrel is approximately 15.6 mcg/day over a period of 3 years.
Disease: contraception
Therapeutic area: Women health
Country: USA
Trial
details: The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception. (NCT00995150)
Latest
news: * On April 28, 2015, Actavis 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 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. 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.
