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The levonorgestrel-releasing intrauterine system (LNG-IUS) is an established, long-acting contraceptive option. With the widespread use of the LNG-IUS, drug-reported adverse events (AEs) have also garnered significant attention. In this study, we conducted a real-world analysis using the FDA's Adverse Event Reporting System (FAERS) database to assess the incidence of AEs associated with LNG-IUS use. Data from FAERS spanning from 2004Q1 to 2024Q1 were reviewed, with a focus on reports in which LNG-IUS was the primary suspected and secondary suspect drug. Signal detection was carried out utilizing Standardized MedDRA Queries (SMQ) and Preferred Terms (PT), with reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) employed to identify Signals of Disproportionate Reporting (SDR) for AEs. A positive SDR was defined when all three methods indicated significance. Analysis of 13 SMQs revealed notable SDRs in ear and eye disorders, cardiac arrhythmias, and lipodystrophy. Of the 61 suspected SDRs identified at the PT level, nearly half were not previously documented in labeling. Key potential signals of AEs associated with LNG-IUS use included increased heart rate, papilledema, idiopathic intracranial hypertension, cervical dysplasia, ruptured ovarian cyst, and uterine embedment and perforation. The findings underscore the importance of signal detection using FAERS data for identifying safety concerns related to LNG-IUS. Long-term observational studies are warranted to confirm and further elucidate these potential safety signals.

To compare the treatment efficacies of high-intensity focused ultrasound (HIFU), HIFU combined with gonadotrophin-releasing hormone agonist (GnRH-a), and HIFU combined with GnRH-a and levonorgestrel-releasing intrauterine system (LNG-IUS) for adenomyosis.We conducted a literature search in SCIENCE DIRECT, COCHRANE LIBRARY, WILLEY ONLINE LIBRARY, PUBMED, and TAYLOR FRANCIS. A total of 471 articles identified, 12 were included in a systematic review, and 11 of them deemed quantitively eligible included in the meta-analysis. The efficacies of the three treatment regimens were assessed using the dysmenorrhea and menstrual scores at 3, 6, 12, 24 months.Of the three regimens, HIFU combined with GnRH-a and LNG-IUS provides the best outcome. On dysmenorrhea score at 6 months there was significantly different higher heterogeneity with P

Study Objective: To evaluate the feasibility and effectiveness of hysteroscopic suture fixation of the levonorgestrel-releasing intrauterine system (LNG-IUS) for the treatment of adenomyosis., Design: A retrospective case series., Setting: Two teaching hospitals with the technology of hysteroscopic suture fixation of the LNG-IUS., Patients: The study reviewed 79 adenomyosis patients who received the hysteroscopic suture fixation of the LNG-IUS from January 2021 to May 2022., Intervention: Hysteroscopic suture fixation of the LNG-IUS to the posterior uterine wall with nondissolvable suture., Measurements and Main Results: All patients underwent one-year postoperative follow-up to evaluate the LNG-IUS expulsion rate, postoperative efficacy, and side effects. Two patients (2.6%) experienced expulsion of the LNG-IUS at 8 months and 12 months postoperatively, respectively. The visual analog pain scale, pictorial blood loss assessment chart score and carbohydrate antigen 125 markedly decreased after the suture fixation of the LNG-IUS compared with baseline in all patients (p <.001). Hemoglobin increased significantly (p <.001). The most common side effect was irregular bleeding, which accounted for 44.3%. The second common side effect was weight gain, which accounted for 29.2%. The composite effectiveness based on pain and bleeding showed that the effective treatment rates at 1, 3, 6, and 12 months after surgery were 92.4%, 97.4%, 96.2%, and 97.4% respectively., Conclusions: Hysteroscopic suture fixation of the LNG-IUS to the uterine fundus was associated with low expulsion rates and significantly improved dysmenorrhea and bleeding., (Copyright © 2023 AAGL. Published by Elsevier Inc. All rights reserved.)

To compare the treatment efficacies of high-intensity focused ultrasound (HIFU), HIFU combined with gonadotrophin-releasing hormone agonist (GnRH-a), and HIFU combined with GnRH-a and levonorgestrel-releasing intrauterine system (LNG-IUS) for adenomyosis. We conducted a literature search in SCIENCE DIRECT, COCHRANE LIBRARY, WILLEY ONLINE LIBRARY, PUBMED, and TAYLOR FRANCIS. A total of 471 articles identified, 12 were included in a systematic review, and 11 of them deemed quantitively eligible included in the meta-analysis. The efficacies of the three treatment regimens were assessed using the dysmenorrhea and menstrual scores at 3, 6, 12, 24 months. Of the three regimens, HIFU combined with GnRH-a and LNG-IUS provides the best outcome. On dysmenorrhea score at 6 months there was significantly different higher heterogeneity with P < 0.00001 (I 2  = 100% WMD 21.44 [6.34, 36.53]) with statistical significance P = 0.005. At 12 months there was significantly different higher heterogeneity P < 0.00001 (I 2  = 100% WMD 23.47 [6.00, 40.94]) with statistically significant P < 0.008. At 24 months there was significantly different higher heterogeneity P < 0.0005 (I 2  = 92% WMD 6.05 [4.81, 7.30]) with statistical significance P < 0.00001. HIFU combined with GnRH-a and LNG-IUS on menstrual score at 3 months was significantly different higher heterogeneity with P < 0.00001 (I 2  = 100% WMD 56.23 [16.01, 96.45]) with statistical significance P = 0.006. At 6 months there was significantly different higher heterogeneity P < 0.00001 (I 2  = 99% WMD 93.86 [64.15, 123.57]) with statistical significance P < 0.00001. At 12 months there was significantly different higher heterogeneity P < 0.00001 (I 2  = 99% WMD 97.13 [67.81, 126.46]) with statistical significance P < 0.00001 compared to treatments with only HIFU and HIFU combined with GnRH-a. HIFU combined with GnRH-a and LNG-IUS treatment is more effective than only HIFU monotherapy and HIFU combined with GnRH-a., Competing Interests: Declaration of competing interest We have no conflicts of interest to disclose., (Copyright © 2023. Published by Elsevier B.V.)

To map and assess evidence regarding use of the levonorgestrel-releasing intrauterine system (LNG-IUS) and its association with breast cancer, we conducted a systematic review and meta-analysis. A search strategy was developed using the terms "Levonorgestrel-releasing," "LNG-IUS," "intrauterine system," and "breast cancer. The electronic databases searched were MEDLINE, Embase, Cochrane Library, Latin American & Caribbean Health Sciences Literature, and Google Scholar for studies published until August 2020. We included observational studies: prospective or retrospective cohort, case-control, and cross-sectional. A total of 494 studies were identified, 294 studies were evaluated by title and abstract, and 262 were excluded because they did not meet the inclusion criteria. A total of 32 studies were read in full, and 24 were excluded. Thus, eight studies were included in the systematic review. The meta-analysis included four studies (two cohort and two case-control studies). Two subgroup analyses were performed for different study designs. The estimated relative risk for the two cohort studies (144,996 cases), with moderate-quality evidence, was 0.93 (95% confidence interval [CI], 0.840-1.03). The odds ratio estimated for the two case-control studies (5556 cases and 35987 controls), with moderate-quality evidence, was 1.07 (95% CI, 0.91-1.26). Evidence of an increased risk of breast cancer was not observed in levonorgestrel-releasing intrauterine system users., (Copyright © 2021. Published by Elsevier Inc.)

Research Question: How does use of a levonorgestrel-releasing intrauterine system (LNG-IUS) in infertile women with endometrial hyperplasia without atypia affect endometrial hyperplasia regression and pregnancy rates compared with oral medroxyprogesterone acetate (MPA)?, Design: This prospective cohort study included 215 infertile women with an indication for assisted reproductive technology (ART) and a diagnosis of endometrial hyperplasia without atypia. Endometrial hyperplasia was diagnosed by hysteroscopic endometrial biopsy. At the time of first- and second-line treatment, patients were offered therapy with either oral MPA 10 mg daily or LNG-IUS. Follow-up biopsies were scheduled after 90 days' treatment. After endometrial hyperplasia regression, patients were admitted to IVF/intracytoplasmic sperm injection (ICSI) cycles., Results: Baseline characteristics and confounders including age at diagnosis, body mass index and duration of infertility did not differ between LNG-IUS users and control participants and were accounted for using propensity score weighting. Endometrial hyperplasia regression rate at first follow-up was higher in the LNG-IUS group than the oral progestins group (28/28, 100% and 110/187, 58.8%; P < 0.001), while that after second-line treatment was comparable between the two groups (89/91, 97.8% and 122/124, 98.4%; P = 0.22). Clinical pregnancy rate, miscarriage rate and cumulative live birth rate following ART in patients ever receiving LNG-IUS were similar to those of patients receiving only MPA (34% versus 39.5%, 22.6% versus 34.7% and 26.4% versus 25.8%)., Conclusion: Endometrial hyperplasia regression is greater in women receiving LNG-IUS compared with oral MPA, while live birth rates following ART are comparable between the two groups. The use of LNG-IUS does not jeopardize the chances of pregnancy in women seeking fertility treatment., (Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Study Objective: The immunohistochemical expression of isoform B of the progesterone receptor (PRB) has shown promising results in predicting the response of atypical endometrial hyperplasia (AEH) and early endometrial cancer (EEC) to conservative treatment. We aimed to calculate the accuracy of PRB as a predictive marker of conservative treatment outcome in AEH or EEC., Design: Retrospective cohort study., Setting: University of Naples Federico II, Naples, Italy., Patients: Thirty-six consecutive premenopausal women <45 years of age with AEH (n = 29) or EEC (n = 7) conservatively treated from January 2007 to June 2018 were retrospectively assessed., Interventions: All patients had been treated with hysteroscopic resection plus levonorgestrel-releasing intrauterine device insertion and followed for at least 1 year. The immunohistochemical expression of PRB was separately assessed in the glands and stroma of the lesion and dichotomized as "weak" or "normal.", Measurement and Main Results: The treatment outcomes considered were (1) treatment failure (i.e., a combined outcome including no regression or recurrence); (2) no regression; and (3) recurrence. The predictive accuracy of PRB immunohistochemistry was assessed by calculating sensitivity (SE), specificity (SP), and area under the receiver operating characteristic curve (AUC). A weak glandular PRB expression showed SE = 70%, SP = 77%, and AUC = 0.74 for treatment failure; SE = 66.7%, SP = 70%, and AUC = 0.68 for no regression; and SE = 75%, SP = 68.8%, and AUC = 0.72 for recurrence. A weak stromal PRB expression showed SE = 100%, SP = 53.8%, and AUC = 0.77 for treatment failure; SE = 100%, SP = 46.7%, and AUC = 0.73 for no regression; and SE = 100%, SP = 43.8%, and AUC = 0.72 for recurrence., Conclusion: A weak stromal PRB expression is a highly sensitive predictive marker of both no response and recurrence of AEH and EEC conservatively treated., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)

Objectives: Few studies, with contradictory results, evaluate intrauterine contraceptives (IUC) and sexual function specifically. This study compares perception of sexual desire related to IUC use and aspects of sexual function in women who use the Lng-IUS with those using the Cu-IUD., Study Design: A secondary analysis regarding IUC use based on a larger cross-sectional survey of contraceptive use in Sweden, conducted in 2013. In total, 153 IUC users (103 Cu-IUD and 50 Lng-IUS users) answered the questionnaire. The only inclusion criterion was intrauterine contraceptive use., Main Outcome Measures: Were self-reported sexual desire changes related to contraceptive method. We also analysed aspects of sexual functioning; sexual desire level, sexual activity, orgasm frequency, satisfaction with sex life and satisfaction of desire level., Results: A negative effect on sexual desire due to contraceptive method was reported by 28% of the Lng-IUS users and by 10.1% of the Cu-IUD users (p < 0.05). Results were more marked after adjusting for age, body mass index, depression, parity, switching behaviour, and partnership (OR 5.0; CI: 1.8-13.8). The adjusted odds of reporting low sexual desire level (never or almost never feeling sexual desire) (OR 3.5; CI: 1.1-11.2) as well as low satisfaction with sex life (OR 2.7; CI: 1.2-6.3) was higher in the Lng-IUS group (adjusted for same confounders as above)., Conclusions: The women in this study using the Lng-IUS more often report negative sexual desire effects of their contraception as well as lower sexual desire level compared with women using the Cu-IUD., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: This study sought to identify knowledge gaps and attitudinal barriers to prescribing intrauterine contraception (IUC)., Methods: A national, Web-based survey of Canadian gynaecology (GYN) and family medicine (FM) physicians was conducted. The survey was distributed through several channels, including physicians' databases, invitations through a commercial email aggregating service, and contacting residency programs. For knowledge-based questions, correct answers were those consistent with Canadian practice guidelines. Ethics approval was granted through Queen's Health Sciences Research Ethics Board. Project funding was through a research grant from Bayer, Inc. (Canadian Task Force Classification III)., Results: A total of 600 responses were received. GYN physicians' knowledge about IUC (number correct / 40) was better than that of the FM and FM with additional women's health training (FMWH) groups (median [interquartile range] 39 [37-40], 36 [32-38], and 37 [35-39]; P < 0.0001). Factors associated with lower scores included rural practice location, lack of affiliation with medical trainees, extremes of practice duration, and self-perceived lack of knowledge about IUC. Most respondents prescribed IUC (93.7%). Among prescribers, 97.0% inserted IUC. The most common reasons for not prescribing or inserting IUC included lack of training, lack of comfort, and referral to other physicians to provide this service. Respondents indicated that they would be more likely to prescribe and/or insert IUC if cost barriers were removed, patient interest was increased, or if there was improved access to patient-centred educational materials and hands-on training modules., Conclusion: This study suggests that although many GYN and FM physicians are offering IUC, misconceptions regarding contraindications still exist, and several barriers are related to deficiencies in providers' knowledge. Therefore, educational efforts should be prioritized to increase the usage of IUC., (Copyright © 2018 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.)

Objectives: To report placement success rate, and ease and pain associated with placement, of the levonorgestrel-releasing intrauterine system (LNG-IUS) 8 using the modified EvoInserter® placement device., Study Design: This was a pooled analysis using data from three previously reported Phase III studies in nulliparous (83.3%) or parous (16.7%) women aged 12-35 years (N=965). LNG-IUS 8 was placed using the modified Evolnserter®. The main outcomes assessed were placement success, ease of placement as reported by healthcare professionals (HCPs), pain at placement as reported by participants, and assessment of the EvoInserter® placement device by HCPs., Results: LNG-IUS 8 placement using the modified EvoInserter® with an insertion tube diameter of 3.8 mm was successful in 99.5% of subjects. HCPs rated the placement procedure as "easy" in 91.6% of cases. Placement pain was reported as absent by 19.1% of participants, as mild by 39.3%, as moderate by 31.6%, and as severe by 10.0%. Overall 89.2% of HCPs completely agreed that the device was easy to prepare and 85.7% completely agreed that placement of an LNG-IUS was easy/simple with the EvoInserter®. Post hoc exploratory analyses indicated a significant association between ease/pain of placement and patient age and between pain of placement and parity., Conclusions: The modified Evolnserter® was associated with a high placement success rate, ease of placement, and manageable pain, and was assessed to have a user-friendly design. These findings suggest that the EvoInserter® may remove some concerns among HCPs about difficult placement of LNG-IUSs, thereby encouraging increased uptake of an effective contraceptive., Implications Statement: Results reported in this study further strengthen evidence of the high placement success rate, ease of deployment, and manageable pain associated with the modified EvoInserter® placement device. These findings might reduce concerns among HCPs about placement of LNG-IUSs, meaning uptake of such contraceptives is increased., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Across the Asia-Pacific region, approximately 38% of pregnancies are unintended. Long-acting reversible contraception, such as intrauterine contraception (IUC), is effective in reducing unintended pregnancy., Objective: This study aims to review access to, uptake of and influencing factors on IUC use in the Asia-Pacific region., Methods: We searched PubMed and MEDLINE for articles published between 1990 and 2015. We identified and reviewed primary studies that examined the following points and were relevant to the Asia-Pacific region: available types and utilization rates of IUC and factors that influence these. We also obtained the opinions of local experts to gain a better understanding of the situation in specific countries., Results: Types of IUC used and utilization rates vary widely across the region. Factors influencing rates of utilization relate to healthcare systems, such as government policy on and subsidization of IUC, types of healthcare providers authorized to place IUC and local guidelines on preinsertion screening. Healthcare provider factors include concerns around pelvic inflammatory disease and the suitability of IUC in certain groups of women, whereas end-user factors include lack of awareness of IUC, concerns about safety, cultural or religious attitudes, access to IUC and costs., Conclusions: Across the Asia-Pacific region, clear data gaps and unmet needs exist in terms of access to and uptake of IUC. We believe that several recommendations are necessary to update future practice and policy for enhanced IUC utilization so that women across this region have better access to IUC., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5mg (average approximate release rate 8μg/24h over the first year; LNG-IUS 8; Jaydess®) in adolescents., Study Design: In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17years) received LNG-IUS 8 for 12months. The primary outcome was the incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included: serious TEAEs, adverse events of special interest, overall user satisfaction, discontinuation rate at 12months, and Pearl Index., Results: LNG-IUS 8 placement was successful in 303/304 participants (99.7%). Overall, 82.6% of participants reported TEAEs, and serious TEAEs and serious study drug-related TEAEs were reported by 7.6% and 1.0% of participants, respectively. No cases of pelvic inflammatory disease, ectopic pregnancy, or uterine perforation were reported. No pregnancies were reported during the 12-month study. At Month 12/study end, the overall user satisfaction rate was 83.9%. Overall, 51 participants (16.8%) prematurely discontinued the study before 12months; 13.8% of participants discontinued owing to TEAEs., Conclusions: No new or unexpected safety events were associated with the low-dose LNG-IUS 8. The safety profile of LNG-IUS 8 in adolescents was consistent with that previously reported in adults. The high overall user-satisfaction rate at study end and the low discontinuation rate over 12months demonstrate that LNG-IUS 8 is a highly acceptable contraceptive method among adolescents., Implications: This study is the first to assess the low-dose levonorgestrel intrauterine system LNG-IUS 8 (average approximate release rate 8μg/24h over the first year and total content 13.5mg) specifically in females<18years of age and confirms the safety and efficacy of LNG-IUS 8 in an adolescent population., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: This study compares the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a low-dose combined oral contraceptive (COC) in reducing adenomyosis-related pain and bleeding., Materials and Methods: A randomized clinical trial included 62 participants complaining of pain and bleeding that was associated with adenomyosis. Participants were randomly assigned to either LNG-IUS or COC treatment. The outcomes included the improvement of pain using a visual analogue scale, menstrual blood loss using a menstrual diary and estimated uterine volume by ultrasound for 6 months of treatment. We also compared uterine arteries and intramyometrial Doppler indices before and 6 months after treatment with both LNG-IUS and COCs., Results: Both treatments significantly reduced pain after 6 months of use; however, the reduction was greater in the LNG-IUS group (from 6.23±0.67 to 1.68±1.25) compared with the COCs group (from 6.55±0.68 to 3.90±0.54). Both treatment arms significantly decreased the number of bleeding days, uterine volume and Doppler blood flow in the uterus from before to after treatment. These effects were more significant in the LNG-IUS arm compared with the COC arm., Conclusion: Both LNG-IUS and COCs decreased the pain and menstrual bleeding that is associated with adenomyosis. However, LNG-IUS is more effective than the COCs in reducing pain and menstrual blood loss. This effect may be secondary to the decrease in uterine volume and the increase in blood flow resistance., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to assess the presence of ovarian cysts in women using a new low-dose levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 13.5mg [total content])., Study Design: A Phase 3 study assessed LNG-IUS 13.5mg use in healthy women with regular menstrual cycles who requested contraception. Transvaginal ultrasonography was performed at screening, baseline, and 3, 6, 9, 12, 18, 24, 30, and 36 months after placement., Results: A total of 1432 women, mean age 27.2±4.8 years, were studied. A total of 10,446 transvaginal ultrasound examinations were performed over 3 years. Ovarian cysts were present in 1.6, 1.1, 2.3, 2.1, 2.4, 2.0, 2.1, 2.2, 1.9, and 2.1% of participants at screening, baseline, and Months 3, 6, 9, 12, 18, 24, 30, and 36, respectively. One hundred first-time ovarian cysts were identified from baseline through Month 9. The size distribution through Month 12 was ≤30 mm (13%), >30 to ≤50 mm (74%), >50 to ≤80 mm (11%), and >80 mm (0%). The overall persistence of ovarian cysts from one examination to the next in Year 1 was 12% (11/90 with follow-up). Cyst persistence was 36% from baseline to 3 months, 13% from 3 to 6 months, 10% from 6 to 9 months, and 0% from 9 to 12 months. The likelihood of cyst persistence increased for cysts >50mm (36%) as compared to those ≤50 mm (8%)., Conclusion: Ovarian cysts were present in 1.6% of women at screening, 2.0 to 2.4% of LNG-IUS 13.5mg users during Year 1, and 1.9 to 2.1% during Years 2 and 3. The majority were >30 to ≤50 mm in size. The small and diminishing number of persistent cysts-decreasing to 0% from 9 to 12 months-suggests that they were functional in nature., Implications: Transvaginal ultrasound follow-up of women during a 3-year clinical trial of LNG-IUS 13.5mg showed that ovarian cysts were present in 1.6% of participants at screening and 1.1-2.4% at each subsequent visit. Eighty-eight percent were ≤5cm, with none >8cm. No ovarian cysts persisted beyond Month 9, suggesting a functional etiology., (Copyright © 2015 Elsevier Inc. All rights reserved.)

There are multiple advantages to "extended use" of the intrauterine device (IUD) use beyond the manufacturer-approved time period, including prolongation of contraceptive and non-contraceptive benefits. We performed a literature review of studies that have reported pregnancy outcomes associated with extended use of IUDs, including copper IUDs and the levonorgestrel intrauterine system (LNG-IUS). Among parous women who are at least 25 years old at the time of IUD insertion, there is good evidence to support extended use of the following devices: the TCu380A and the TCu220 for 12 years, the Multiload Cu-375 for 10 years, the frameless GyneFix® (330 mm²) for 9 years, the levonorgestrel intrauterine system 52 mg (Mirena®) for 7 years and the Multiload Cu-250 for 4 years. Women who are at least 35 years old at the time of insertion of a TCu380A IUD can continue use until menopause with a negligible risk of pregnancy. We found no data to support use of the LNG-IUS 13.5 mg (Skyla®) beyond 3 years. When counseling about extended IUD use, clinicians should consider patient characteristics and preferences, as well as country- and community-specific factors. Future research is necessary to determine the risk of pregnancy associated with extended use of the copper IUD and the LNG-IUS among nulliparous women and women less than 25 years old at the time of IUD insertion. More data are needed on the potential effect of overweight and obesity on the long-term efficacy of the LNG-IUS., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Progestogen-only contraceptives (POCs) are suitable for women with thrombophilia and/or a history of venous thromboembolism (VTE). Several of these women, however, use oral anticoagulant therapy (OAT), which can impair the bleeding pattern associated with POC use. We evaluated the effects of OAT use on the bleeding pattern associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) in women with thrombophilia and/or a history of VTE., Study Design: This prospective cohort study followed two groups of women, all of whom were thrombophilic and/or had a history of VTE: OAT users and nonusers. Bleeding patterns, blood pressure, body mass index (BMI), weight, complete blood count and waist circumference were compared between the two groups before and 6 and 12 months after LNG-IUS insertion., Results: The patient cohort consisted of 33 women aged 18 to 45 years old, including 16 OAT users and 17 nonusers. Body weight increased by 3.9% and BMI by 3.8% in OAT users 12 months after LNG-IUS insertion. Hemoglobin and hematocrit levels increased by approximately 10% in both groups. There was no difference between the groups in bleeding patterns, with amenorrhea being the most frequent pattern in both groups (41.2% each) 12 months after LNG-IUS insertion. OAT did not increase the frequency of prolonged and/or frequent bleeding., Conclusion: OAT users and nonusers had similar bleeding patterns after insertion of the LNG-IUS. Hemoglobin and hematocrit levels increased in both groups., (© 2013.)