Liletta-52-mg-IUD-intrauterine-device

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About Liletta

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 6 years. The system should be replaced after 6 years if continued use is desired.

*LILETTA is an intrauterine system, or IUS, otherwise known as an IUD, intrauterine device

THE LILETTA® ACCESS IUS*† TRIAL

The largest hormonal IUD* study conducted exclusively in U.S women2

Designed to evaluate generally healthy women aged 16-45 across a wide range of BMIs (15.8 kg/m2 to 61.6 kg/m2 )1
‍

Evaluated over the course of six years1,5

Open-label, multicenter trial conducted at 29 U.S. study centers over 72 months (N=1751)

Primary Outcome1

Efficacy of LILETTA for pregnancy prevention in nulliparous and parous females of childbearing potential (16-35 years old)

Secondary outcomes

Safety and bleeding patterns
Return of menses after discontinuation

Study population: a study that included a diverse group of women

The ACCESS IUS trial studied LILETTA in 1751 generally healthy patients.1

Efficacy she wants, without daily maintenance,‡ demonstrated for up to 6 years1

Pregnancy rate calculated as the Pearl Index was the primary efficacy endpoint in women aged 16-35.

>99% efficacy at preventing pregnancy for up to 6 years

‡Patients should be counseled to check that LILETTA is in the proper position by feeling the threads once a month. Healthcare providers should re-examine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Reversibility: a long-acting, reversible contraceptive method for up to 6 years1

Pregnancy rates after discontinuation of liletta 1

Pregnancy rate after 6 months discontinuation

Pregnancy rates after 1year discontinuation

Data based on an analysis of 191 women who desired pregnancy after study discontinuation. Conception rates after removal of LILETTA were assessed and appeared consistent with conception rates in the general population of women having regular, unprotected sexual intercourse for 12 months.

References: 1. LILETTA (levonorgestrel-releasing intrauterine system) 52 mg [prescribing information]. Irvine, CA: Allergan USA, Inc., and San Francisco, CA: Medicines360; 2020. 2. Mirena (levonorgestrel-releasing intrauterine system) 52 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2021. 3. Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2021. 4. Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2021. 5. Data on file. Medicines360: San Francisco, CA.

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