R. Carr has no conflicts; his university department receives contraceptive research funding from Medicines360. Michael A. Thomas has no conflicts; his university department receives contraceptive research funding from Evofem, Medicines360, and Sebela. Angelina Gangestad has no conflicts; her university department receives contraceptive research funding from Bayer Healthcare and Medicines360. David L. Eisenberg has served on a Data Safety Monitoring Board for studies sponsored by Sebela, as a trainer for Merck, and on Advisory Boards for Femasys and Medicines360. His university department receives contraceptive research funding from Medicines360. Andrea I. Olariu is a Medicines360 employee. Mitchell D. Creinin has served on Advisory Boards for Merck & Co. and TherapeuticsMD and is a consultant for Danco, Estetra, Mayne and Medicines360. His university department receives contraceptive research funding from Daré, HRA Pharma, Medicines360, Merck & Co. and Sebela. The research funding from Medicines360 includes medical oversight of all Liletta® development studies.
Objective: To assess 6-year contraceptive efficacy and safety of a levonorgestrel 52mg intrauterine system (IUS). Study Design: We assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n=1751) in an ongoing 10-year phase-3 trial. Results: Over six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI .44-1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6. Conclusion: This levonorgestrel 52mg IUS is a highly effective and safe contraceptive over 6 years of use. Implications: The levonorgestrel 52mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.
status, income quartile, patient urban-rural designation, hospital geographic region and hospital teaching status. We compared data to visits by women in the same age range without an EC diagnosis. Z-tests were performed to assess any significant differences between groups. RESULTS: The estimated number of encounters for EC in the ED decreased significantly during the study period.
Women account for half of new infections with HIV annually. Heterosexual transmission is the most common route of infection in resource limited settings (RLS). An effective microbicide would help decrease transmission of HIV and potentially enable women to have more control in sexual relationships. Research into microbicides is done predominantly in RLS. In addition, there will be different issues and challenges to consider with respect to rectal microbicide use in men. There exist several ethical issues around microbicide development and clinical research which we explore in this review. Respect for persons, including autonomy and protection of vulnerable populations, beneficence, and justice are explored as they relate to microbicide research. Improving standards of care in RLS, trial design, and informed consent are discussed in more detail. Special populations including pregnant women, adolescents, and men who have sex with men are considered in more detail. A multipronged approach to HIV prevention will be necessary to have an impact on HIV prevention. A continued discussion around ethical issues in regard to study design, interpretation of results and implementation of compounds brought to market will remain critically important.
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