A novel estetrol-containing combined oral contraceptive: European expert panel review.

PURPOSE: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation. MATERIALS AND METHODS: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination. Their findings are presented as a narrative review. RESULTS: E4 15 mg/DRSP 3 mg in a 24/4 regimen provided effective contraception with good cycle control, characterised by a predictable regular bleeding pattern and minimal unscheduled bleeding, together with a good safety profile. The combination was associated with high user satisfaction, well-being, and minimal changes in body weight. The effects on endocrine and metabolic parameters were limited, and the combination was found to have a limited impact on liver function and lipid and carbohydrate metabolism. Moreover, its effect on several haemostatic parameters was lower than that of comparators containing ethinyl oestradiol (EE) 20 µg/DRSP 3 mg and EE 30 µg/levonorgestrel 150 µg. CONCLUSION: E4 15 mg/DRSP 3 mg provides safe and effective contraception, with high user satisfaction and predictable bleeding. Further research will evaluate the long-term safety of the COC.

A novel estetrol-containing combined oral contraceptive: European expert panel review.

PURPOSE: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation. MATERIALS AND METHODS: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination. Their findings are presented as a narrative review. RESULTS: E4 15mg/DRSP 3 mg in a 24/4 regimen provided effective contraception with good cycle control, characterised by a predictable regular bleeding pattern and minimal unscheduled bleeding, together with a good safety profile. The combination was associated with high user satisfaction, wellbeing, and minimal changes in body weight. The effects on endocrine and metabolic parameters were limited, and the combination was found to have a limited impact on liver function and lipid and carbohydrate metabolism. Moreover, its effect on several haemostatic parameters was lower than that of comparators containing ethinyl oestradiol (EE) 20mg/DRSP 3 mg and EE 30mg/levonorgestrel 150mg. CONCLUSION: E4 15 mg/DRSP 3 mg provides safe and effective contraception, with high user satisfaction and predictable bleeding. Further research will evaluate the long-term safety of the COC.

Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 - a secondary analysis of the EURAS-IUD study.

OBJECTIVE: To conduct a secondary analysis of continuation, unwanted effects and cost consequences at 1 year in copper intrauterine device (IUD) users aged under 30 in the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD study) based on IUD type. METHODS: Descriptive and comparative analyses of copper IUD continuation, unwanted effects and estimated cost consequences at 1 year were performed in users aged under 30 based on IUD copper surface area, shape or design, width and arms' flexibility. RESULTS: 5796 copper IUD users were identified to have been aged under 30 at EURAS-IUD study recruitment and data for 5762 users (99.4%) was analysed. Higher IUD continuation, fewer unwanted effects and lower costs were observed with IUDs of the lowest copper content (<300mm2), horse-shoe frame design, widths 18 mm to <30mm and flexible IUD arms. Discontinuation, unwanted effects and costs were greater with frameless IUDs and framed, ≥30mm width IUDs with 380mm2 of copper and copper bands on their rigid transverse IUD arms. CONCLUSIONS: Significant differences in continuation, reported unwanted effects and estimated costs at 1 year between IUD types were observed in users aged under 30. Although further research is needed, clinicians should consider these findings when counselling and choosing IUD types for younger women.

Improving uptake of the copper intrauterine device for emergency contraception by educating pharmacists in the community.

OBJECTIVES: The copper intrauterine device (Cu-IUD) is the most effective method of emergency contraception (EC) and provides ongoing contraception, yet few women choose this option. This study evaluates the impact of an educational initiative involving pharmacists on uptake of Cu-IUDs for EC in an integrated sexual health clinic in the North East of England. METHODS: Since November 2010, local pharmacists have received intensive education detailing EC options including Cu-IUDs. At the same time a rapid access referral pathway for fitting of an emergency Cu-IUD was established. The impact of this initiative has been assessed by analysing case notes of women attending a large city centre sexual health service who received an emergency Cu-IUD during September and October 2010 (prior to the initiative) and the same 2 months in 2011 (9 months after the start of the intervention). RESULTS: The number of women fitted with an emergency Cu-IUD increased by almost three-fold from 11 fitted in September and October 2010 to 30 fitted in these 2 months in 2011. One woman was referred from a pharmacist to the service in the first audit period compared with 17 in the second. No pregnancies occurred in the first month after Cu-IUD insertion in these 41 women. CONCLUSIONS: Educating pharmacists has increased referral and uptake of Cu-IUD used for EC and this has the potential to reduce unintended pregnancies now and in the future.

Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives.

Few studies in the scientific literature provide clear direction on the prevention or management of pain associated with intrauterine contraceptive (IUC) placement. Those that have been published have studied small numbers of women and fail to provide definitive conclusions. There are also no guidelines available detailing recognised standard approaches to this problem. The consensus recommendations in this review focus primarily on non-pharmacological and often non-evidence-based interventions. This review includes general considerations, practical recommendations for both routine and more difficult cases and guidance on the optimal choice of instruments. General considerations, including pre-insertion counselling, the setting for the procedure, the confidence and technique of the provider and the interplay between the provider and assistant, can influence women's level of anxiety and, in turn, influence their perception of pain and their overall experience. Further studies are required to refine the optimal strategy for managing pain associated with IUC insertion.

Use of and attitudes towards emergency contraception: a survey of women in five European countries.

OBJECTIVE: To identify knowledge of and attitudes towards emergency contraception (EC) in women from five European countries. METHODS: In an internet-based survey, sexually active women aged 16 to 46 years from France, Germany, Italy, Spain, and the UK were asked about their use of and opinions on EC. RESULTS: Overall, 7170 women completed the survey. Thirty percent reported having had unprotected sexual intercourse during the previous 12 months (population at risk). Twenty-four percent of the population at-risk reported using EC. The most common reasons given for not using EC were: not perceiving themselves to be at risk of pregnancy; and not thinking about EC as an option. A third of respondents indicated they did not know how EC works, with several misconceptions about EC noted e.g., leading to infertility, similar to abortion. Seventy-nine percent of women agreed that EC is a responsible choice to prevent unwanted pregnancy, but nearly a third of women who used EC felt uncomfortable or judged when obtaining it. CONCLUSIONS: EC is underutilised by three-quarters of the women surveyed. Women do not recognise they may be at risk of pregnancy when contraception fails. There are still several misbeliefs about EC indicating a need for better education of the public.

Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview.

Bleeding irregularities are one of the major reasons for discontinuation of oral contraceptives (OCs), and therefore clinicians need to set expectations during consultations. In this review we provide an overview of bleeding data of recently marketed cyclic combined OCs (COCs) and one progestin-only pill (POP). We evaluated data from phase 3 trials (≥12 months) used to gain regulatory approval. Overall, each type of OC has its own specific bleeding pattern. These patterns however were assessed by using different bleeding definitions, which hampers comparisons between products. In COCs, the estrogen balances the effects of the progestin on the endometrium, resulting in a regular bleeding pattern. However, this balance seems lost if a too low dose of ethinylestradiol (EE) (e.g., 10 µg in EE/norethindrone acetate 1 mg) is used in an attempt to lower the risk of venous thromboembolism. Replacement of EE by 17ß-estradiol (E2) or E2 valerate could lead to suboptimal bleeding profile due to destabilization of the endometrium. Replacement of EE with estetrol (E4) 15 mg in the combination with drospirenone (DRSP) 3 mg is associated with a predictable and regular scheduled bleeding profile, while the POP containing DRSP 4 mg in a 24/4 regimen is associated with a higher rate of unscheduled and absence of scheduled bleeding than combined products.

Recommendations for standardization of bleeding data analyses in contraceptive studies.

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contraceptive is designed to result in a predictable or unpredictable bleeding pattern. Predictable pattern outcomes quantify days of scheduled, unscheduled and no bleeding, while unpredictable pattern outcomes assess frequency. Flow is quantified based on patient comparisons to their typical flow when not using contraception, with spotting representing no menstrual products use. Duration of a prolonged bleeding and/or spotting episode is more than 7 days. Studies should assess bleeding characteristics for a minimum of 12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables, and the full duration of use for long-acting contraceptives. Describing pattern, flow and duration as independent categories allows a fuller understanding of the bleeding outcomes and better future assessments of acceptability and continuation. Standardization of outcomes permits better comparison between studies and data synthesis; standardization will also improve the ability of clinicians and patients to understand differences between products.

Consensus-led recommendations supporting choice and personalisation of Hormone replacement therapy in menopause care.

OBJECTIVE: Inequity of access and choice to different hormone replacement therapy (HRT) products across the UK has been suggested (Hillman, 2020). While, the cause is not entirely understood, potential contributors include conflicting national guidance, economic deprivation and a local formulary approach. With a diverse and growing population of women reaching and living well beyond the menopause, the impact of this inequity is becoming more pronounced, and challenges the goal of providing personalised care. The study objective is to establish a consensus that supports a greater equity of access and choice of HRT and provision of individualised care. STUDY DESIGN: Modified Delphi study designed by UK HCPs with expertise in menopause care. This group identified 40 consensus statements over four key topics, related to access and choice of different HRT products. An online 4-point Likert scale questionnaire, sent to UK HCPs, was used to assess agreement, with a consensus threshold set at 75%. MAIN OUTCOME MEASURES: 150 HCP responses between June and September 2021. RESULTS: A total of 137 responses were received. Analysis identified 37/40 statements attaining very high agreement (≥ 90%) and 3/40 statements attaining high agreement (< 90% and ≥75%). Nine recommendations were developed with the intent to inform potential improvements to menopause care in the UK. CONCLUSIONS: The high levels of agreement displayed suggest a desire to change the way menopause care is delivered in the UK. Implementation of the suggested recommendations has the potential to improve equity of access to licensed treatment options, compliant with the NICE recommendation for personalisation of care.

Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17ß-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen.

OBJECTIVES: The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17ß-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). METHODS: Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 µg) in a 21/7-day regimen (n=535) for 13 cycles. RESULTS: Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. CONCLUSIONS: These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

A Review of Clinical Guidelines on the Management of Iron Deficiency and Iron-Deficiency Anemia in Women with Heavy Menstrual Bleeding.

INTRODUCTION: Up to one-third of women of reproductive age experience heavy menstrual bleeding (HMB). HMB can give rise to iron deficiency (ID) and, in severe cases, iron-deficiency anemia (IDA). AIM: To review current guidelines for the management of HMB, with regards to screening for anemia, measuring iron levels, and treating ID/IDA with iron replacement therapy and non-iron-based treatments. METHODS: The literature was searched for English-language guidelines relating to HMB published between 2010 and 2020, using the PubMed database, web searching, and retrieval of clinical guidelines from professional societies. RESULTS: Overall, 55 guidelines mostly originating from North America and Europe were identified and screened. Twenty-two were included in this review, with the majority (16/22) focusing on guidance to screen women with HMB for anemia. The guidance varied with respect to identifying symptoms, the criteria for testing, and diagnostic hemoglobin levels for ID/IDA. There was inconsistency concerning screening for ID, with 11/22 guidelines providing no recommendations for measurement of iron levels and four contrasting guidelines explicitly advising against initial assessment of iron levels. In terms of treatment, 8/22 guidelines provided guidance on iron therapy, with oral iron administration generally recommended as first-line treatment for ID and/or IDA. Four guidelines recommended intravenous iron administration for severe anemia, in non-responders, or before surgery. Three guidelines provided hemoglobin thresholds for choosing between oral or intravenous iron treatment. Four guidelines discussed the use of transfusion for severe IDA. CONCLUSION: Many of the guidelines for managing HMB recognize the importance of treating anemia, but there is a lack of consensus in relation to screening for ID and use of iron therapy. Consequently, ID/IDA associated with HMB is likely to be underdiagnosed and undertreated. A consensus guidance, covering all aspects of screening and management of ID/IDA in women with HMB, is needed to optimize health outcomes in these patients.

Women who bleed heavily during menstruation are at risk of iron deficiency and anemia. This can have a negative effect on the well-being of women and can cause serious complications after surgery. Iron is an important part of the hemoglobin in red blood cells that carries oxygen around the body. Bleeding causes iron to be lost from the body. If there is heavy blood loss, iron stores in the body can become low, leading to iron deficiency. If the iron deficiency is severe enough to impair red blood cell production, iron-deficiency anemia can develop. We reviewed the current guidelines for the care of women with heavy menstrual bleeding, focusing on the detection and treatment of iron deficiency and anemia. Most guidelines include routine testing for anemia. Fewer guidelines consider measuring iron levels. Not all the guidelines include advice on the best way to treat iron deficiency and anemia. For those that do, the recommendations vary and sometimes offer conflicting advice. There is little agreement on when to give iron therapy, and whether this should be given by mouth or by infusion. A lack of clear guidance on detecting and treating iron deficiency and anemia caused by heavy menstrual bleeding puts women at risk of being undiagnosed and untreated. To address these concerns, the authors recommend the development of consensus guidelines. These should contain comprehensive recommendations on all aspects of the diagnosis and management of iron deficiency and anemia in women with heavy menstrual bleeding.

50 years of "The Pill": celebrating a golden anniversary.

The past 50 years have seen great advances in combined oral contraceptives (COCs) that have resulted in reduced risks of adverse events and improved cycle control. The most important changes in COCs over time include repeated lowering of the estrogen dose, development of new progestogens, and the reduction or elimination of the pill-free interval. Most recently, formulations that deliver estradiol in lieu of ethinylestradiol have been introduced. The advantages of COCs generally far outweigh the disadvantages. Current options in oral contraception include a wide spectrum of products that enable clinicians to choose the most appropriate formulation for individual women. This article summarises the advances in oral contraceptives over time and describes the most current clinical data regarding the use of COCs.

Efficacy of contraceptive methods: a review of the literature.

OBJECTIVES: To provide a comprehensive and objective summary of contraceptive failure rates for a variety of methods based on a systematic review of the literature. METHODS: Medline and Embase were searched using the Ovid interface from January 1990 to February 2008, as well as the reference lists of published articles, to identify studies reporting contraceptive efficacy as a Pearl Index or life-table estimate. Reports that recruited less than 400 subjects per study group and those covering less than six cycles/six months were excluded. In addition, unlicensed products or those not internationally available, emergency contraception, and vasectomy studies were excluded. RESULTS: Information was identified and extracted from 139 studies. One-year Pearl Indices reported for short-acting user-dependent hormonal methods were generally less than 2.5. Gross life-table rates for long-acting hormonal methods (implants and the levonorgestrel releasing-intrauterine system [LNG-IUS]) generally ranged between 0-0.6 per 100 at one year, but wider ranges (0.1-1.5 per 100) were observed for the copper intrauterine devices (0.1-1.4 per 100 for Cu-UIDs with surface area ≥ 300 mm2 and 0.6-1.5 per 100 for those with surface area < 300 mm2). Barrier and natural methods were the least effective. CONCLUSIONS: Our review broadly confirms the hierarchy of contraceptive effectiveness in descending order as: (1) female sterilisation, long-acting hormonal contraceptives (LNG-IUS and implants); (2) Cu-IUDs with ≥ 300 mm2 surface area; (3) Cu-IUDs with < 300 mm2 surface area and short-acting hormonal contraceptives ( injectables, oral contraceptives, the patch and vaginal rings), (4) barrier methods and natural methods.

Efficacy of contraceptive methods: A review of the literature.

OBJECTIVES: To provide a comprehensive and objective summary of contraceptive failure rates for a variety of methods based on a systematic review of the literature. METHODS: Medline and Embase were searched using the Ovid interface from January 1990 to February 2008, as well as the reference lists of published articles, to identify studies reporting contraceptive efficacy as a Pearl Index or life-table estimate. Reports that recruited less than 400 subjects per study group and those covering less than six cycles/six months were excluded. In addition, unlicensed products or those not internationally available, emergency contraception, and vasectomy studies were excluded. RESULTS: Information was identified and extracted from 139 studies. One-year Pearl Indices reported for short-acting user-dependent hormonal methods were generally less than 2.5. Gross life-table rates for long-acting hormonal methods (implants and the levonorgestrel releasing-intrauterine system [LNG-IUS]) generally ranged between 0-0.6 per 100 at one year, but wider ranges (0.1-1.5 per 100) were observed for the copper intrauterine devices (0.1-1.4 per 100 for Cu-IUDs with surface area > or =300 mm( 2 ) and 0.6-1.5 per 100 for those with surface area <300 mm( 2 )). Barrier and natural methods were the least effective. CONCLUSIONS: Our review broadly confirms the hierarchy of contraceptive effectiveness in descending order as: (1) female sterilisation, long-acting hormonal contraceptives (LNG-IUS and implants); (2) Cu-IUDs with > or =300 mm( 2 ) surface area; (3) Cu-IUDs with <300 mm( 2 ) surface area and short-acting hormonal contraceptives (injectables, oral contraceptives, the patch and vaginal ring), and (4) barrier methods and natural methods.

Best Practices for Counseling Adolescents about the Etonogestrel Implant.

Among young persons, ease of use, high efficacy, and high acceptability makes the etonogestrel contraceptive implant an important choice for this age group. Adolescent-friendly, patient-centered counseling considers the patient's cognitive development, the influence of friends and family, as well as their own preferences and values. Age-appropriate language, graphics, and models are useful to explain contraceptive options and relevant side effects. Effectiveness, reversibility, safety, noncontraceptive benefits, and side effects are important attributes and should be discussed when teens are choosing a contraceptive method. In this review we describe suggested best practices for counseling adolescents about the etonogestrel implant so they can make informed, prudent decisions about using this contraceptive method.

Contraceptive choice for young people.

BACKGROUND AND METHODOLOGY: Giving young women access to newer contraceptives such as the combined contraceptive patch, combined contraceptive vaginal ring and single-rod implant may help reduce teenage pregnancies. However, little is known about young people's attitudes towards these contraceptives. This cross-sectional survey, using a self-completion questionnaire, aimed to explore young people's attitudes towards these contraceptives in order to develop understanding of the choices they make about contraception. Participants were a self-selecting sample of young women attending contraception clinics in Newcastle upon Tyne, UK. Statistical analysis was carried out using appropriate univariate tests. Qualitative analysis involved identification of key themes, which were continuously challenged by looking for conformity and variation and by identifying disconfirming cases. RESULTS: The majority of the 127 participants had no prior knowledge of the patch, vaginal ring or implant. Interest in using these contraceptives was low. Associations were found between their attitude towards using them and the participants' age, experience of pregnancy scares, experience of unplanned pregnancies and prior knowledge of the contraceptives. Six major themes emerged relating to the advantages and disadvantages of these contraceptives and included convenience, effectiveness, safety along with side effects, invasiveness and discretion. DISCUSSION AND CONCLUSIONS: Young people's knowledge of and attitudes towards these contraceptives was variable and may have been influenced by experience and access to information. Themes identified from perceptions of these contraceptives are useful in developing understanding of what young people look for in contraceptives. Health professionals should provide information on these themes when assisting young people in making informed decisions about contraception.

Provision of contraception services and advice for women with cystic fibrosis.

BACKGROUND AND METHODOLOGY: As the prognosis of patients with cystic fibrosis (CF) improves, issues of sexual health, fertility, pregnancy and contraception are increasingly important. In order to plan the provision of a contraception and sexual health service for women with CF we studied their sexual and reproductive history, their current usage of contraception, the sources and quality of advice they had received, and their particular needs using a confidential questionnaire sent to all women over 16 years of age attending a regional CF centre. RESULTS: Of 55 women (mean age 29.7 years) surveyed, 42 (76%) responded. Thirty-three women (79%) were sexually active and 13 (31%) had experienced 19 pregnancies, five (26%) of which were unplanned. Only half of the women who responded were using contraception. No woman used female sterilisation, the progestogen implant, intrauterine system (IUS) or copper-bearing intrauterine device (IUD) for contraception. Twenty-six (62%) women reported not having received contraceptive advice specific to CF and 24 (57%) said that they had not been warned about the potential interaction between broad-spectrum antibiotics and the combined pill. DISCUSSION: Women with CF have a relatively high rate of unplanned pregnancy and do not receive optimal advice or use the full range of contraceptive methods. CF teams lack training in contraception and contraceptive services may not have a detailed knowledge of CF and its complications. New strategies are needed to focus the knowledge and skills of both teams in providing better services for women with CF.

Higher discontinuation rate with a standard-sized compared to a small-sized 'gold standard' copper intrauterine device: a case-control review.

BACKGROUND: T-shaped intrauterine devices (IUDs) with a copper surface area of 380 mm2 and copper bands on the transverse arms are the most effective types of copper-containing IUDs. A small-sized 'gold standard' IUD is available but there has been little research to compare the effects of this small-sized IUD to its standard-sized counterpart. AIM: To determine discontinuation rates and reasons for discontinuation at 1 year of the small-sized Mini TT380 Slimline IUD compared with the standard-sized TT380 Slimline. METHODS: The clinical records of women fitted with Mini TT380 Slimline ('mini') IUDs were compared with those of women fitted with standard-sized TT380 Slimline ('standard') IUDs over a 3-year period (2013-2016). RESULTS: Clinical records were available for 67 women fitted with a mini IUD (mean age 23 years, 64% nulliparous) and 63 women fitted with a standard IUD (mean age 25 years, 39% nulliparous). At 1 year, twice as many standard IUD users (32%, n=20) had discontinued their IUD use compared with mini IUD users (15%, n=10). Complaints of pain and bleeding were more than double (70%, n=14) in those women who discontinued standard IUD use compared with those who discontinued using the mini IUD (30%, n=3). These differences were statistically significant and were unrelated to parity. CONCLUSIONS: More women using a standard-sized 'gold standard' IUD rather than its smaller counterpart complained of pain and bleeding, leading to higher discontinuation at 1 year. More research on the association between size and discontinuation of these IUDs is needed.

Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

OBJECTIVES: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. STUDY DESIGN: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. RESULTS: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). CONCLUSION: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.