Menstrual cup use and intrauterine device expulsion in a copper intrauterine device randomized trial.

OBJECTIVE: To evaluate menstrual cup use and intrauterine device (IUD) expulsion. STUDY DESIGN: We performed a secondary analysis of a 3-year contraceptive efficacy trial comparing two copper 380 mm2 IUDs. Investigators randomized participants approximately 1:4 to the TCu380A or NTCu380-Mini IUD. Approximately 12 months after enrollment began, we advised participants against menstrual cup use due to observed IUD expulsions in cup users. We evaluated IUD expulsion (including spontaneous partial and complete expulsion and accidental self-removal) at 12 and 36 months. We used multivariable logistic regression to evaluate IUD expulsion by age, baseline menstrual volume, body mass index, IUD type, menstrual cup use, parity, and uterine length. RESULTS: This analysis included 1046 participants (203 TCu380A and 843 NTCu380-Mini), with 879 (84.0%) nulliparas. Through 12 and 36 months, expulsion occurred in 74 (7.1%, 95% CI 5.5-8.6%) and 133 (12.7%, 95% CI 10.7-14.7%) participants, respectively. Overall, 250 (23.9%) reported menstrual cup use. More menstrual cup users than non-users experienced expulsion through 12 months (32/203 [15.8%] vs. 42/843 [5.0%]) and 36 months (58/250 [23.2%] vs. 75/796 [9.4%]). Through 36 months, NTCu380-Mini menstrual cup users had higher expulsion odds, while TCu380A cup users did not. Menstrual cup users more frequently experienced accidental self-removal than non-users in participants using the TCu380A (3/53 [5.7%] vs. 0/150 [0.0%]) and the NTCu380-Mini (20/197 [10.2%] vs. 7/646 [1.1%]). In multivariable regression, we found increased odds of expulsion through 36 months in participants using menstrual cups with the NTCu380-Mini (aOR 3.13, 95% CI 1.16-8.46) and <25 years (aOR 1.59, 95% CI 1.07-2.34). CONCLUSIONS: We found higher odds of IUD expulsion with menstrual cup and concurrent NTCu380-Mini IUD use over 36 months of use, but not with concurrent TCu380A IUD use. Menstrual cup users experienced higher likelihood of accidental self-removal regardless of IUD type. IMPLICATIONS: Menstrual cup and NTCu380-Mini use may increase IUD expulsion risk and may increase accidental self-removal risk with TCu380A and NTCu380-Mini use. Clinicians should advise patients of these risks and consider warning patients using an IUD shaped like the NTCu380-Mini (Nova-T frames) of expulsion risk with menstrual cup use.

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial.

STUDY QUESTION: Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWER: In terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADY: An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. STUDY DESIGN, SIZE, DURATION: From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. PARTICIPANTS/MATERIALS, SETTING, METHODS: We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. MAIN RESULTS AND THE ROLE OF CHANCE: We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. LIMITATIONS, REASONS FOR CAUTION: We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. WIDER IMPLICATIONS OF THE FINDINGS: The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. STUDY FUNDING/COMPETING INTEREST(S): Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. TRIAL REGISTRATION NUMBER: NCT04120337. TRIAL REGISTRATION DATE: 9 October 2019. DATE OF FIRST PATIENT'S ENROLMENT: 23 December 2019.

Recap of the sixth international symposium on intrauterine devices and systems for women's health.

Due to the COVID-19 pandemic, the Sixth International Symposium on Intrauterine Devices and Systems for Women's Health was held as a series of seven 2-hour webinars between May 28, 2020, and June 22, 2021. This Symposium featured 48 different presenters and moderators covering a wide range of topics to highlight new IUD issues and update general IUD knowledge, just as it was done in previous symposia dating back to 1962 [1-5]. A total of 1346 people attended remotely to observe the events live. In this article, we share summaries of the presentations from the sixth symposium. These summaries, provided by the presenters, are meant to archive the symposium. This article gives the reader an overview of the topics and identifies the sessions' moderators and speakers charged with providing the content. Those interested in further detail, references, and information about the speakers can find more information on the conference website: www.iud2020.com. After the summaries, we share ideas for future IUD research and programmatic needs, as provided by Symposium's presenters and organizers. The authors' summaries are personal opinions and do not necessarily reflect the perspectives of the Symposium's organizers or the medical community at large. The Symposium was recorded and the sessions are available for viewing free of charge at the website, www.iud2020.comor on YouTube. As of July 2022, approximately 1700 visitors have viewed the recordings.

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively. Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

Hand-held device to remove a single-rod subdermal contraceptive implant: Results of early trials in Sweden.

OBJECTIVE: Long-acting reversible contraceptives (LARCs) such as subdermal implants and intrauterine devices are promoted and increasingly used worldwide. Hence, in the light of this we also need to ensure easy access to the reversibility, i.e. emphasise the R in LARC. Our overall aim is to develop a device to facilitate implant removals. We evaluated the safety and performance of the two initial field prototypes where the main outcome was percentage of successful fixations and secondary outcomes were percentage of successful removals without the use of additional tools, duration of the procedure, satisfaction and adverse events. STUDY DESIGN: We performed a feasibility study including 41 subjects. RESULTS: We estimated a fixation rate of 35/41 (85%) and an overall removal rate of 24/41 (59%). Further, we measured that the median time for removals was 80 s and that subjects and operators were satisfied with the procedure. We recorded adverse events such as bruising and superficial abrasions. CONCLUSIONS: The device demonstrated a successful fixation rate, however, the removal rate will need to be further improved. IMPLICATIONS: This feasibility study shows that the device has potential and further research is needed to modify and optimize the device.

Menstrual bleeding and spotting with the Levonorgestrel Intrauterine System (52 mg) during the first-year after insertion: a systematic review and meta-analysis.

BACKGROUND: Changes in menstrual bleeding concern many users of the 52 mg Levonorgestrel Intrauterine System. Prescribing information for Levonorgestrel Intrauterine System devices describe an overall decrease in bleeding and spotting days over time; however, estimates derived from a variety of existing clinical data are currently unavailable. OBJECTIVE: The objective of the study was to systematically calculate the mean days of bleeding-only, spotting-only, and bleeding and/or spotting experienced by a population of reproductive-aged Levonorgestrel Intrauterine System users with normal regular menses prior to insertion during the first year of use. DATA SOURCES: We identified clinical trials, including randomized controlled trials and randomized comparative trials, as well as cohort studies published in English between January 1970 and November 2018 through searching 12 biomedical and scientific literature databases including MEDLINE and ClinicalTrials.gov. STUDY ELIGIBILITY CRITERIA: We considered studies that reported data on Levonorgestrel Intrauterine System devices releasing 20 µg of levonorgestrel per day, collected daily menstrual bleeding data for at least 90 consecutive days, defined bleeding and spotting per World Health Organization standards and evaluated participants with normal regular menses prior to insertion. STUDY APPRAISAL AND SYNTHESIS METHODS: We assessed study quality using established guidelines. Two reviewers independently conducted all review stages and rated the quality of evidence for each article; any disagreements were resolved by a third. Where possible, we pooled data using a random-effects model. RESULTS: Among 3403 potentially relevant studies, we included 7 in our meta-analysis. We calculated the mean days of bleeding-only, spotting-only, and bleeding and/or spotting for the first four 90 day intervals after Levonorgestrel Intrauterine System insertion. Combined menstrual bleeding and/or spotting days gradually decreased throughout the first year, from 35.6 days (95% confidence interval, 32.2-39.1) during the first 90 day interval to 19.1 (95% confidence interval, 16.6-21.5), 14.2 (95% confidence interval, 11.7-16.8), and 11.7 days (95% confidence interval, 9.7-13.7) in the second, third, and fourth intervals. Measures for bleeding-only and spotting-only days similarly decreased throughout the first year, with the greatest decreases occurring between the first and second intervals. CONCLUSION: Our study provides 90 day reference period measures that characterize menstrual patterns for Levonorgestrel Intrauterine System users with normal regular menses prior to insertion during the first year of use. Our findings provide broader generalizability and more detail than patterns described in the prescribing information. These findings quantify an overall decrease in menstrual bleeding days with longer duration of use, with the greatest decrease occurring between months 3 and 6. Accurately establishing expectations with the Levonorgestrel Intrauterine System may improve informed selection and decrease discontinuation.

Opportunity, satisfaction, and regret: Trying long-acting reversible contraception in a unique scientific circumstance.

Increased use of long-acting reversible contraception (LARC) can reduce unintended pregnancies. However, significant barriers exist to LARC uptake, particularly high up-front costs. In North Carolina in 2014, we interviewed thirty-four purposively selected participants (aged 20-30 years) enrolled in a partially randomized patient preference trial to learn about their experiences with and attitudes toward contraception in this unique trial context. Cost of LARC was important in participants' decision-making. Experiencing an unintended pregnancy motivated women to switch to LARC. No participants who tried LARC, even those who experienced side effects, regretted it. Several participants regretted discontinuing their LARC. Concerns about insertion and removal did not influence future willingness to try LARC. Participants discussed the importance of affordability and feeling in control when choosing a contraceptive method. Cost, combined with uncertainty over whether LARC is the right method for them, may deter young women from trying LARC. Intrauterine devices (IUDs) and implants should be made affordable so that women can try them without significant financial commitment. Affordability will likely increase uptake, which will reduce unintended pregnancies. Regret from discontinuing LARC was more frequently reported than regret from trying LARC. Providers should offer young women LARC and counsel to support continuation.

Levonorgestrel intrauterine system associated amenorrhea: a systematic review and metaanalysis.

OBJECTIVE DATA: Amenorrhea is a polarizing noncontraceptive effect of the levonorgestrel intrauterine system. Composite amenorrhea prevalence estimates that summarize all clinical data for the first-year after insertion currently are not available. The purpose of this study was to investigate the validity of existing prevalence estimates by the systematic calculation of amenorrhea measures for a general population of levonorgestrel intrauterine system users and to provide 90-day interval point estimates for the first year of use. STUDY: We identified clinical trials, randomized controlled trials, and randomized comparative trials that were published in English between January 1970 and September 2017 through electronic searches of 12 biomedical and scientific literature databases that included MEDLINE and ClinicalTrials.gov. STUDY APPRAISAL AND SYNTHESIS METHODS: We considered studies that clearly defined amenorrhea per World Health Organization standards (the complete cessation of bleeding for at least 90 days), collected data from written daily bleeding diaries (the gold standard data collection technique on menstrual bleeding changes), and evaluated levonorgestrel intrauterine system devices that released 20 µg of levonorgestrel per day. We assessed study quality using guidelines established by the US Preventive Services Task Force and Cochrane handbook for systematic reviews of interventions. Two reviewers independently conducted all review stages; disagreements were resolved by a third reviewer. Where possible, data were pooled with the use of a random-effects model. RESULTS: Of 2938 potentially relevant studies, we included 9 in our meta-analysis. We calculated amenorrhea prevalence, which was weighted for inter- and intrastudy variance, for 4 90-day intervals and months 0-12. Our results demonstrated few levonorgestrel intrauterine system users (0.2%; 95% confidence interval, 0.0-0.4) experienced amenorrhea during the first 90 days after insertion; however, prevalence increased to 8.1% (95% confidence interval, 6.6-9.7) on days 91-180. Finally, 18.2% (95% confidence interval, 14.9-21.5) of users experienced amenorrhea for at least 1 90-day interval during the first year. Although interstudy heterogeneity limited reliability of days 181-271 and 272-365 measures, prevalence increased from 13.6% (95% confidence interval, 9.3-18.0) to 20.3% (95% confidence interval, 13.5-27.0), respectively. CONCLUSION: Approximately 20% of levonorgestrel intrauterine system users experience amenorrhea during at least 1 90-day interval by the first year after insertion. This composite estimate is consistent with the product labeling and demonstrates that most users do not experience amenorrhea during the first year. These results provide accurate summary measures to facilitate counselling and informed method selection.

Not seeking yet trying long-acting reversible contraception: a 24-month randomized trial on continuation, unintended pregnancy and satisfaction.

OBJECTIVES: To measure the 24-month impact on continuation, unintended pregnancy and satisfaction of trying long-acting reversible contraception (LARC) in a population seeking short-acting reversible contraception (SARC). STUDY DESIGN: We enrolled 916 women aged 18-29 who were seeking pills or injectables in a partially randomized patient preference trial. Women with strong preferences for pills or injectables started on those products, while others opted for randomization to LARC or SARC and received their methods gratis. We estimated continuation and unintended pregnancy rates through 24months. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also examined how satisfaction levels varied by cohort and how baseline negative LARC attitudes were associated with satisfaction over time. RESULTS: Forty-three percent chose randomization, and 57% chose the preference option. Complete loss to follow-up was<2%. The 24-month LARC continuation probability was 64.3% [95% confidence interval (CI): 56.6-70.9], statistically higher than SARC groups [25.5% (randomized) and 40.0% (preference)]. The 24-month cumulative unintended pregnancy probabilities were 9.9% (95% CI: 7.2-12.6) (preference-SARC), 6.9% (95% CI: 3.3-10.6) (randomized-SARC) and 3.6% (95% CI: 1.8-6.4) (randomized-LARC). Statistical tests for comparing randomized groups on unintended pregnancy were mixed: binomial at 24-month time point (p=.02) and log-rank survival probabilities (p=.14 for first pregnancies and p=.07 when including second pregnancies). LARC satisfaction was high (80% happy/neutral, 73% would use LARC again, 81% would recommend to a friend). Baseline negative attitudes toward LARC (27%) were not clearly associated with satisfaction or early discontinuation. CONCLUSIONS: The decision to try LARC resulted in high continuation rates and substantial protection from unintended pregnancy over 24months. Despite participants' initial desires to begin short-acting regimens, they had high satisfaction with LARC. Voluntary decisions to try LARC will benefit large proportions of typical SARC users. IMPLICATIONS: Even women who do not necessarily view LARC as a first choice may have a highly satisfying experience and avoid unintended pregnancy if they try it.

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

BACKGROUND: Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. OBJECTIVE: The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. STUDY DESIGN: We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. RESULTS: Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow-up at 12 months was <2%. The 12-month method continuation probabilities were 63.3% (95% confidence interval, 58.9-67.3) (preference short-acting reversible contraception), 53.0% (95% confidence interval, 45.7-59.8) (randomized short-acting reversible contraception), and 77.8% (95% confidence interval, 71.0-83.2) (randomized long-acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12-month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1-8.7) (preference short-acting reversible contraception), 7.7% (95% confidence interval, 3.3-12.1) (randomized short-acting reversible contraception), and 0.7% (95% confidence interval, 0.0-4.7) (randomized long-acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short-acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short-acting reversible contraception randomized group and short-acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy-eight percent of randomized long-acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short-acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). CONCLUSION: Even in a typical population of women who presented to initiate or continue short-acting reversible contraception, long-acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long-acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short-acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short-acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual-care preference group. Benefits of increased voluntary uptake of long-acting reversible contraception may extend to wider populations than previously thought.

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant.

STUDY QUESTION: Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER: The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY: The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. STUDY DESIGN SIZE, DURATION: For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan-Meier (K-M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. MAIN RESULTS AND THE ROLE OF CHANCE: Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K-M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2-1.8] and 0.8 per 100 W-Y [95% CI: 0.2-2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5-6.5]. LIMITATIONS, REASONS FOR CAUTION: Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. WIDER IMPLICATIONS OF THE FINDINGS: The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the product's capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. TRIAL REGISTRATION: The trial was registered as ISRCTN33378571. STUDY FUNDING/COMPETING INTERESTS: The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.