Newly Published Data from Phase 3 Clinical Trial of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Confirms Efficacy, Safety, and Tolerability Through Five Years

Data from ACCESS IUS, the largest ongoing Phase 3 clinical trial in the U.S. of an intrauterine system evaluating pregnancy prevention, also reports bleeding profile over five years in diverse women

SAN FRANCISCO – Medicines360, a global nonprofit women’s health pharmaceutical company, announced newly published data finding that LILETTA is highly efficacious in preventing pregnancy over five years of use. In addition, the publication reports data related to the bleeding profile of LILETTA over the same time period. “Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52 mg Intrauterine System” was recently published online by the American Journal of Obstetrics & Gynecology.

The findings are based on the largest ongoing Phase 3 intrauterine system (IUS) clinical trial in the U.S. The trial, “ACCESS IUS,” (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), follows 1,751 U.S. women who received LILETTA. According to the study, LILETTA is more than 99 percent effective in preventing pregnancy for up to five years in a broad range of women. LILETTA is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

This latest study publication from the ACCESS IUS trial also describes rates of amenorrhea (defined as no bleeding or spotting in the preceding 90 days) for LILETTA through five years of continued use. The study reported that nearly half (42 percent) of the women in the trial had amenorrhea at the end of five years of use. During the same time period, 90 percent of women experienced only amenorrhea, spotting, or light bleeding. In the trial, 2.2% of women discontinued the use of LILETTA due to bleeding complaints.

Medicines360 received initial FDA approval of LILETTA in February 2015 and in October 2018, the product received an updated indication for up to five years of pregnancy prevention. Since it was introduced in 2015, Medicines360 and Allergan, a global pharmaceutical company, have partnered to expand access to LILETTA to women regardless of income or insurance coverage.

“It’s our mission to increase access to effective health care for all women. The latest results from ACCESS IUS are extremely encouraging as they demonstrate LILETTA’s effectiveness and safety for pregnancy prevention in a broad range of women and provide insight into its bleeding profile,” said Jessica Grossman, M.D., CEO of Medicines360. “Coupled with our nonprofit business model, we hope this new evidence leads to more clinics offering more women affordable long-acting reversible contraception options.”

The cost of contraception can prohibit many women from obtaining an option that is appropriate for them. This is a significant public health concern. As a nonprofit pharmaceutical company committed to addressing gaps in access to women’s healthcare, Medicines360 continues to pursue affordable and effective solutions that work for all women.

“As more women in the U.S. request long-acting reversible contraception, especially hormonal IUSs, demonstrating a five-year duration of use for LILETTA is important for both women’s health and public health,” said Mitchell D. Creinin, M.D., Professor of Obstetrics and Gynecology and Director of Family Planning at the University of California, Davis and an author of the manuscript. “When an IUS, such as LILETTA, is approved for a longer duration of use, women may see potential benefits such as fewer insertion and removal procedures, which in turn may help decrease healthcare costs over time.”

Medicines360 sponsored and designed the ACCESS IUS study and oversees its conduct, including funding the trial and providing all study product free of charge to participants.

ABOUT LILETTA®

Indication

LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years.

Important Risk Information About LILETTA

  • Do not use LILETTA if you:
    • Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
    • Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
    • Have an untreated lower genital infection now
    • Have had an infection from an abortion within the last 3 months
    • Can get infections easily; for example, if you:
      • Have problems with your immune system
      • Have multiple sexual partners or your partner has multiple sexual partners
      • Use or abuse intravenous drugs
    • Have or suspect you might have cancer of the uterus or cervix
    • Have bleeding from the vagina that has not been explained
    • Have short-term (acute) liver disease or liver tumor
    • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
    • Have an intrauterine system (IUS) in your uterus already
    • Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
    • Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate
  • Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature labor or delivery can occur with pregnancies that continue with an IUS
  • Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
  • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop
  • Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
  • Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
  • LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women
  • LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
  • Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs. 

For full prescribing information, visit www.LILETTA.com.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with global and US partners. Medicines360, through its subsidiary Impact RH360, launched the Avibela Project to expand access to hormonal IUDs in low- and middle-income countries. For more information, visit medicines360.org

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AVIBELA can be made available in the following 88 countries

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  7. Botswana
  8. Burkina Faso
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  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
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  28. Ghana
  29. Grenada
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  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
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  48. Mali
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  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.