Phase 3 Study Evaluates Two Investigational Hormone-Releasing IUDs for Prevention of Pregnancy for up to Three Years
WAYNE, N.J., Oct. 22, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced results of a Phase 3 study evaluating two investigational levonorgestrel-releasing intrauterine systems (IUDs), LNG-IUS12 and LNG-IUS16. The findings were accepted for presentation during an oral abstract session at the American Society for Reproductive Medicine (ASRM) 68th Annual Meeting.
"The data we observed are encouraging for both investigational IUDs," said Anita Nelson, M.D., presenting author and Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Nearly half of all pregnancies in the U.S. are unintended, highlighting the need for continued research into effective and long-acting birth control options for women."
Results from the Phase 3 Study
The global, randomized, Phase 3, open-label study (ASRM abstract #0-16) included 2,884 women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception. Study participants were randomized to either LNG-IUS12 (n=1,432), which had an in vitro release rate of 12 µg /day, or LNG-IUS16 (n=1,452), a second investigational IUD with an in vitro release rate of 16 µg/day. Among those who participated in the study, 39% had never had a child (nulliparous) while the remainder had at least one child (parous).
The Pearl Index (PI) was the primary efficacy endpoint used to assess contraceptive reliability. The PI is based on pregnancies that occurred after the start of treatment and within seven days after IUD removal or expulsion. The unadjusted three-year Pearl Indices (95% CI) were 0.33 for LNG-IUS12 and 0.31 for LNG-IUS16. Cumulative failure rates over three years were 0.9% for LNG-IUS12 and 1.0% for LNG-IUS16. Serious adverse events included six cases of pelvic inflammatory disease (PID, two with LNG-IUS12 and four with LNG-IUS16); one partial uterine perforation with LNG-IUS16 and 10 ectopic pregnancies (three with LNG-IUS12 and seven with LNG-IUS16). Six additional cases of PID were also observed. The cumulative risk of expulsion over three years was 4.56% for LNG-IUS12 and 3.58% for LNG-IUS16.
"We are pleased by these data and are developing both investigational hormone-releasing IUDs as part of our ongoing commitment to women's healthcare innovation," said Pamela Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.
LNG-IUS12 and LNG-IUS16 are being investigated for the prevention of pregnancy for up to three years and are not approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other health authorities.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
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Posted: October 2012