Browsing by Subject "IUD"

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    Association of Baseline Bleeding Pattern on Amenorrhea with Levonorgestrel Intrauterine System Use
    (Elsevier, 2016-11) MEJIA, Manuela; MCNICHOLAS, Colleen; MADDEN, Tessa; PEIPERT, Jeffrey F.; Obstetrics and Gynecology, School of Medicine
    OBJECTIVE To evaluate the effect of baseline bleeding patterns on rates of amenorrhea reported at 12 months in LNG (levonorgestrel) 52 mg IUS (intrauterine system) users. We also assessed the effect of baseline bleeding patterns at three and six months post-insertion. STUDY DESIGN In this secondary analysis of the Contraceptive CHOICE Project, we included participants who had a LNG-IUS inserted within one month of enrollment and continued use for 12 months. Using 12-month telephone survey data, we defined amenorrhea at 12 months of use as no bleeding or spotting during the previous six months. We used chi-square and multivariable logistic regression to assess the association of baseline bleeding pattern with amenorrhea while controlling for confounding variables. RESULTS Of 1802 continuous 12-month IUS users, amenorrhea was reported by 4.9%, 14.8% and 15.4% of participants at three, six, and 12 months, receptively. Participants with light baseline bleeding or short duration of flow reported higher rates of amenorrhea at three and six months post-insertion (p<0.03), while LNG-IUS users with heavy or prolonged flow were less likely to report amenorrhea at 3 and 6 months (p<0.03). In a multivariable analysis, participants with self-reported heavy bleeding at baseline were less likely to report amenorrhea at 12 months than those who reported moderate bleeding (ORadj, 0.36; 95% CI, 0.16–0.69). CONCLUSION Women with heavier menstrual bleeding are less likely than women with moderate flow to report amenorrhea following 12 months of LNG-IUS use.
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    Prolonged Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device - Two Years Beyond FDA-Approved Duration
    (Elsevier, 2017-06) McNicholas, Colleen; Swor, Erin; Wan, Leping Wan; Peipert, Jeffrey F.; Medicine, School of Medicine
    The subdermal contraceptive implant, and the 52mg levonorgestrel intrauterine device (IUD) are currently FDA-approved for three and five years of use respectively. Limited available data has suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. Objective To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method for two years beyond the current FDA-approved duration. Study Design We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel IUD for a minimum of 3 and 5 years, respectively (started IUD in 2007 or later or implant in 2009 or later). Demographic and reproductive health histories, as well as objective body mass index (BMI) were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rates, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using chi-square test and Fisher Exact test, and compared serum ENG levels stratified by body mass index using the Kruskal-Wallis test. Results Implant users (n=291) have contributed 444.0 women-years of follow-up. There have been no documented pregnancies in implant users during the two years of post-expiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (one-sided %97.5 confidence interval (CI) 0–1.48) per 100 woman years at four years and 0 (one-sided %97.5 CI 0–2.65) per 100 women years at five years. Among 496 levonorgestrel IUD users, 696.9 women-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the levonorgestrel IUD is calculated as 0.25(%95 CI 0.04–1.42) per 100 women year; failure rate during the seventh year is 0.43 (%95 CI 0.08–2.39) per 100 women years. Among implant users with serum etonogestrel results, the median etonogestrel level at the time of method expiration was 207.7 pg/mL (range 63.8–802.6 pg/mL), 166.1 pg/mL (range 67.9 25.0 – 470.5 pg/mL) at the end of the fourth year, and 153.0 pg/mL (range 72.1–538.8 pg/mL) at the end of the fifth year. Median ENG levels were compared by BMI at each time point and a statistical difference was noted at the end of four years of use with overweight women having the highest serum ENG (195.9 pg/ml: range 25.0–450.5) when compared to normal (178.9 pg/ml: range 87.0–463.7) and obese (137.9 pg/ml: range 66.0–470.5) women (p=0.04). Conclusion This study indicates that the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for at least two additional years of use. Serum etonogestrel evaluation demonstrates median levels remain above the ovulation threshold of 90pg/ml for women of in all BMI classes.