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Few longitudinal studies have measured contraceptive continuation past one year in Sub-Saharan Africa. We surveyed 674 women who had been randomized to receive the three-month intramuscular contraceptive injectable (DMPA-IM), levonorgestrel (LNG) implant, or copper IUD during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in South Africa and Zambia and were subsequently followed for two additional years to explore method continuation, reasons for discontinuation, and access to implant and IUD removal services. We also conducted in-depth qualitative interviews with 39 participants. We estimated cumulative discontinuation probabilities using Kaplan-Meier estimates and assessed factors associated with discontinuation using Cox-proportional hazards models. The LNG implant continuation rate over the maximum 44-month study period was 60%, while rates for the copper IUD and DMPA-IM were 52% and 44%, respectively. Reasons for method discontinuation included side effects, particularly menstrual changes, and method stock-outs. Most implant and IUD users who sought removal were able to access services; however, room for improvement exists. In this cohort randomized to receive a contraceptive method and attend regular study visits, implants and IUDs continued to be highly acceptable over an additional two years, but facilities should continue to ensure that insertions and removals are available as requested.

Background Efforts are underway to develop an easy-to-use contraceptive microarray patch (MAP) that could expand the range of self-administrable methods. This paper presents results from a discrete choice experiment (DCE) designed to support optimal product design. Methods We conducted a DCE survey of users and non-users of contraception in New Delhi, India (496 women) and Ibadan, Nigeria (two versions with 530 and 416 women, respectively) to assess stated preferences for up to six potential product attributes: effect on menstruation, duration of effectiveness, application pain, location, rash after application, and patch size. We estimated Hierarchical Bayes coefficients (utilities) for each attribute level and ran simulations comparing women’s preferences for hypothetical MAPs with varying attribute combinations. Results The most important attributes of the MAP were potential for menstrual side effects (55% of preferences in India and 42% in Nigeria) and duration (13% of preferences in India and 24% in Nigeria). Women preferred a regular period over an irregular or no period, and a six-month duration to three or one month. Simulations show that the most ideal design would be a small patch, providing 6 months of protection, that would involve no pain on administration, result in a one-day rash, and be applied to the foot. Conclusions To the extent possible, MAP developers should consider method designs and formulations that limit menstrual side effects and provide more than one month of protection.

Background: The COVID-19 pandemic affected global access to health services, including contraception We sought to explore effects of the pandemic on family planning (FP) service provision and use in South Africa and Zambia, including on implant and intrauterine device (IUD) users’ desire and ability to obtain removal. Methods: Between August 2020 and April 2021, we conducted surveys with 537 women participating in an ongoing longitudinal contraceptive continuation study. We also carried out in-depth interviews with 39 of the survey participants and 36 key informants involved in FP provision. We conducted descriptive analysis of survey responses and thematic analysis of interviews. Results: Contraceptive use changed minimally in this sample with the emergence of COVID-19. Fewer than half of women (n=220) reported attempting to access FP since the start of the pandemic, the vast majority using short-acting methods. Among those who sought services, 95% obtained their preferred method. The proportion of women not using a method before and after pandemic start did not change in Zambia (31%); in South Africa, the proportion increased from 8% to 10%. Less than 7% of implant or IUD users in either country reported wanting removal. Among those who sought removal (n=22), 91% (n=10) in Zambia and 55% (n=6) in South Africa successfully obtained removal. In qualitative interviews, women with challenges accessing FP services mentioned long queues, deprioritization of contraceptive services, lack of transportation, stock-outs, and fear of contracting COVID-19 at a facility. Key informants reported stock-outs, especially of injectables, and staff shortages as barriers. Conclusions: We did not find a substantial impact of COVID-19 on contraceptive access among this sample; however, providers and others involved in service provision identified risks to continuity of care. As the COVID-19 pandemic wanes, it continues to be important to monitor people’s ability to access their preferred contraceptive methods.

Many Ghanaian women seeking implant removal are able to obtain services, but knowledge and access gaps exist., Key Findings Although most contraceptive implant users in Ghana are able to access removal services, barriers, including cost, provider reluctance to remove, and difficult removals, exist.Providers express confidence in removing implants, but many are less confident in their ability to perform difficult removals., Key Implications Family planning programs should review and strengthen potential gaps in removal service provision including access to removals for outreach clients, financial disincentives for removal, and provider training and referral systems for difficult removals.More research is needed to assess the prevalence and consequences of difficult implant removals in different settings., Background: Access to quality removal services is a key component of informed choice in contraceptive implant use; however, limited data exist on users’ access to removal services. In Ghana, implants are available across the country and are the most commonly used contraceptive method among married women. Methods: From October 2017 and January 2018, we conducted a phone survey with a stratified random sample of 1,159 women who had obtained an implant from a public-sector Ghana Health Service clinic in 2 regions and 1,073 women who had an implant inserted through Marie Stopes International Ghana (MSIG) mobile outreach in 2 other regions. We also interviewed 50 women just after receiving an implant removal from MSIG. We conducted follow-up in-depth interviews with 20 implant acceptors and 15 implant providers across the 4 study regions. Results: More than four-fifths of women in both service delivery contexts knew that their implant could be removed before its labeled duration. Nearly half of public sector clients and one-third of outreach clients reported that their provider only told them of removal access at the place of insertion. Among women obtaining their implant in the public and outreach sectors, respectively, 32% and 21% reported ever wanting it removed and 61% and 55% who attempted removal obtained a removal on the first attempt. An additional 17% in each context were successful in having their implant removed within 1 week of the first attempt. Most women obtained removal from the same place they received their insertion (81% public, 70% outreach). Most women reported their overall removal experience was very or somewhat easy (74% public, 68% outreach). Challenges included cost, provider availability, interactions with providers, and difficult removals. Conclusions: Access to implant removal is not universal in Ghana. Strengthening removal services in both the public and outreach sectors is needed to ensure comprehensive access.

A significant global unmet need for new contraceptive options for both women and men remains due to side effect profiles, medical concerns, and inconvenience of many currently available products. The pharmaceutical industry has largely abandoned early research and development for contraception and will not likely engage to bring new products to the market unless they have been significantly de-risked by showing promise in early phase clinical trials. This lack of interest by big pharma comes at a time when scientific and technological advances in biology and medicine are creating more opportunities than ever for the development of new and innovative drug products. Novel partnerships between the academic sector, small biotechnology companies, foundations, non-government organizations (NGOs), and the federal government could accelerate the development of new contraceptive products. We discuss the challenges and opportunities that we have encountered as an NGO with a mission to develop novel contraceptive products for low- and middle-income countries and how it differs from developing products for higher-income markets. We hope that our experiences and “lessons learned” will be of value to others as they proceed down the product development path, be it for female or male or for hormonal or nonhormonal contraceptives., Based on our experience and lessons learned as an NGO engaged in contraceptive research, we describe opportunities and challenges facing contraceptive developers outside the pharmaceutical industry across the stages of product development.

Global efforts to improve menstrual health and sexual and reproductive health and rights (SRHR) are fundamentally intertwined and share similar goals for improving health and well-being and increasing gender equality. Historically, however, the two fields have operated independently and missed opportunities to build upon their biological and sociocultural linkages. Biological touchpoints connecting the two fields include genital tract infections, menstrual disorders, contraception, and menopause. From a sociocultural perspective, intersections occur in relation to the experience of puberty and menarche, gender norms and equity, education, gender-based violence, and transactional sex. We describe evidence linking menstrual health and SRHR and offer recommendations for integration that could strengthen the impact of both fields.

Women's concerns about contraceptive-induced menstrual changes can lead to method discontinuation and nonuse, contributing to unmet need for contraception. Research on women's perceptions of amenorrhea related to longer acting methods and in low-income countries is limited.Data were from nationally representative household surveys and focus group discussions with women of reproductive age conducted in Burkina Faso and Uganda in 2016-2017. Bivariate cross-tabulations and multivariate logistic regression analyses were used to examine sociodemographic and reproductive characteristics associated with women's attitudes about contraceptive-induced amenorrhea (n=2,673 for Burkina Faso and 2,281 for Uganda); menstrual health determinants were also examined for Burkina Faso. Qualitative data from focus group discussions were analyzed to understand reasons behind women's attitudes and how they influence contraceptive decision making.Sixty-five percent of women in Burkina Faso and 40% in Uganda reported they would choose a method that caused amenorrhea during use. In Burkina Faso, the predicted probability of accepting amenorrhea was higher for women aged 15-19 (compared with older women), living in rural areas, married and cohabiting (compared with never married), currently using a contraceptive method (compared with never users) and from Mossi households (compared with Gourmantché); menstrual health practices were not associated with amenorrhea acceptability. In Uganda, the least wealthy women had the highest predicted probability of accepting amenorrhea (51%). Qualitative analysis revealed a variety of reasons for women's attitudes about amenorrhea and differences by country, but the relationship between these attitudes and contraceptive decision making was similar across countries.Addressing misconceptions about contraception and menstruation may result in more informed method decision making.Contexto: Las preocupaciones de las mujeres acerca de los cambios menstruales inducidos por los anticonceptivos pueden conducir a la interrupción y el abandono del método, lo cual contribuye a la necesidad insatisfecha de anticoncepción. La investigación sobre la percepción de la amenorrea por parte de las mujeres sobre los métodos de acción más prolongada y en los países de bajos ingresos es limitada. Métodos: Los datos provienen de encuestas representativas de hogares a nivel nacional y discusiones de grupos focales con mujeres en edad reproductiva realizadas en Burkina Faso y Uganda entre 2016 y 2017. Se utilizaron tabulaciones cruzadas bivariadas y análisis de regresión logística multivariada para examinar las características sociodemográficas y reproductivas asociadas con las actitudes de las mujeres con respecto a la amenorrea inducida por anticonceptivos (n = 2,673 para Burkina Faso y 2,281 para Uganda); también se examinaron los determinantes de la salud menstrual en Burkina Faso. Se analizaron datos cualitativos de discusiones de los grupos focales para comprender las razones que determinan las actitudes de las mujeres y cómo influyen en la toma de decisiones sobre anticonceptivos. Resultados: El 65% de las mujeres en Burkina Faso y el 40% en Uganda informaron que elegirían un método que les causara amenorrea durante su uso. En Burkina Faso, la probabilidad predicha de aceptar la amenorrea fue mayor para las mujeres de 15 a 19 años (en comparación con las mujeres mayores), que vivían en zonas rurales, que estaban casadas y cohabitaban (en comparación con las que nunca se habían casado), que actualmente usaban un método anticonceptivo (en comparación con las mujeres que nunca lo habían usado) y de hogares Mossi (en comparación con Gourmantché). Las prácticas de salud menstrual no se asociaron con la aceptabilidad de la amenorrea. En Uganda, las mujeres menos ricas tuvieron la probabilidad más alta de aceptar amenorrea (51%). El análisis cualitativo reveló una variedad de razones con respecto a las actitudes de las mujeres sobre la amenorrea y las diferencias por país, pero la relación entre estas actitudes y la toma de decisiones sobre anticonceptivos fue similar en todos los países. Conclusiones: El abordaje de los conceptos erróneos sobre la anticoncepción y la menstruación podría resultar en una toma de decisiones más informada sobre los métodos anticonceptivos.Contexte: Les inquiétudes des femmes à l'égard des changements menstruels induits par la contraception peuvent conduire à l'arrêt ou à la non-utilisation de la méthode et contribuer ainsi au besoin non satisfait de contraception. La recherche sur les perceptions des femmes de l'aménorrhée liée aux méthodes à durée d'action prolongée et dans les pays à revenu faible est limitée. Méthodes: Les données sont extraites d'enquêtes de ménage nationalement représentatives et de discussions de groupe avec des femmes en âge de procréer, menées au Burkina Faso et en Ouganda en 2016-2017. Les caractéristiques sociodémographiques et reproductives associées aux attitudes des femmes concernant l'aménorrhée induite par la contraception (n=2 673 pour le Burkina Faso et 2 281 pour l'Ouganda) ont été examinées en tableaux croisés bivariés et par analyses de régression logistique multivariée. Les déterminants de la santé menstruelle ont aussi été examinés pour le Burkina Faso. L'analyse des données qualitatives obtenues des discussions de groupe a permis de cerner les raisons à la base des attitudes des femmes et leur influence sur les décisions contraceptives prises. Résultats: Soixante-cinq pour cent des femmes burkinabè et 40% de leurs homologues ougandaises ont déclaré qu'elles choisiraient une méthode dont la pratique causerait l'aménorrhée. Au Burkina Faso, la probabilité prédite d'acceptation de l'aménorrhée s'est avérée supérieure pour les femmes âgées de 15 à 19 ans (par rapport à leurs aînées), vivant en milieu rural, mariées ou en union (par rapport à celles qui n'avaient jamais été mariées), pratiquant actuellement la contraception (par rapport à celles qui ne l'avaient jamais pratiquée) et d'origine Mossi (par rapport à Gourmantché). Les pratiques de santé menstruelle n‘étaient pas associées à l'acceptabilité de l'aménorrhée. En Ouganda, les femmes les moins riches sont associées à la plus haute probabilité prédite d'acceptation de l'aménorrhée (51%). L'analyse qualitative a révélé diverses raisons à la base des attitudes des femmes à l‘égard de l'aménorrhée ainsi que certaines différences suivant le pays, mais la relation entre ces attitudes et la décision contraceptive s'est avérée similaire dans les deux pays. Conclusions: La résolution des idées fausses concernant la contraception et la menstruation pourrait conduire à une prise de décision mieux éclairée dans le choix des méthodes.

An effervescent microneedle patch has been designed for rapid separation of drug-loaded microneedles and long-term contraception., To increase access to long-acting contraception, we developed a reversible contraceptive microneedle patch that is simple-to-administer, slowly releases contraceptive hormone (levonorgestrel) for >1 month, and generates no biohazardous sharps waste. After manually pressing the patch to skin for 1 min, microneedles rapidly separate from the patch within the skin due to effervescence triggered by contact with skin’s interstitial fluid, as demonstrated in rats and human participants. Long-acting contraception is achieved by formulating microneedles with a biodegradable polymer [poly(lactic-co-glycolic) acid] that slowly releases levonorgestrel for ~1 month in vitro. In rats, the patch maintained levonorgestrel concentration above the human contraceptive threshold level for >1 month, and a placebo microneedle patch was well-tolerated in human participants. Women of reproductive age in three continents demonstrated interest in and preference for long-acting contraception by microneedle patch. These studies indicate that an effervescent microneedle patch could facilitate greater access to long-acting contraception.

Background Use of contraception lowers a woman's risk of experiencing an ectopic pregnancy. In the case of method failure, however, progestin-only contraceptives may be more likely to result in ectopic pregnancies than some other methods such as combined hormonal and barrier contraceptives. Objective To describe ectopic pregnancy risk associated with use of implants and progestin-only injectable contraceptives through a systematic review of published studies. Data sources We searched electronic databases for articles in any language published through May 2015 describing studies of progestin-only injectables and implants. We also searched bibliographies and review articles for additional studies. Study selection and extraction Studies that reported any pregnancies were included in the review. Independent data extraction was performed by two authors based on predefined data fields, and where possible, we calculated the proportion of pregnancies that were ectopic and the ectopic pregnancy incidence rate per 1000 woman-years. Results Fifty-three studies of implants and 28 studies of injectables were identified; 79% reported pregnancy location. The proportion of ectopic pregnancy ranged from 0 to 100% with an incidence of 0-2.9 per 1000 woman-years in studies of marketed levonorgestrel implants. Studies of etonogestrel implants and the injectables, depot-medroxyprogesterone acetate and norethisterone enanthate, reported few ectopic pregnancies. Conclusion Progestin-only contraceptive implants and injectables protect against ectopic pregnancy by being highly effective in preventing pregnancy overall; however, the absolute risk of ectopic pregnancy varies by type of progestin. Risk of ectopic pregnancy should not be a deterrent for use or provision of these methods.

Male contraceptive options are limited; however, product development efforts tend to focus on female methods. Research on attitudes toward methods for men-particularly in regions of low contraceptive prevalence, such as Sub-Saharan Africa-could inform the development of new male methods.Qualitative data were taken from focus group discussions with 80 men aged 23-67 and 398 women aged 15-50 conducted in Burkina Faso and Uganda in 2016. Transcripts were analyzed thematically to explore support among men and women for male contraceptive methods, and to extract suggestions about ideal method characteristics.Male and female participants in both countries expressed support for new male contraceptive options; more positive attitudes were expressed in Uganda than in Burkina Faso. Participants of both sexes recognized that male methods could reduce the family planning burden on women and offer men greater control over their fertility; however, some had concerns about side effects and thought that men would not use contraceptives. Relationship characteristics, such as polygamous unions, were cited as possible challenges. In both countries, various delivery methods (e.g., creams or jellies, injections and implants) and durations (from short-acting to permanent) were proposed.The acceptability of new male methods among most participants in the two countries indicates a potential demand for male contraceptives. Options should include a variety of method characteristics to maximize choice, engage men, and support men and women's contraceptive needs.RESUMEN Contexto: Las opciones de anticonceptivos masculinos son limitadas; sin embargo, los esfuerzos de desarrollo de productos tienden a enfocarse en los métodos femeninos. La investigación sobre las actitudes hacia los métodos para hombres, — particularmente en las regiones de baja prevalencia de anticoncepción, como el África subsahariana— podría dar sustento al desarrollo de nuevos métodos masculinos. Métodos: Se tomaron datos cualitativos a partir de discusiones de grupos focales que se llevaron a cabo en Burkina Faso y Uganda en 2016, con la participación de 80 hombres de 23 a 67 años y de 398 mujeres de 15 a 50 años. Las transcripciones se analizaron temáticamente para explorar el apoyo de hombres y mujeres a los métodos anticonceptivos masculinos, así como para extraer sugerencias sobre las características ideales del método. Resultados: Los participantes masculinos y femeninos en ambos países expresaron su apoyo a las nuevas opciones de anticonceptivos masculinos; se expresaron más actitudes positivas en Uganda que en Burkina Faso. Los participantes de ambos sexos reconocieron que los métodos masculinos podrían reducir la carga de planificación familiar para las mujeres y ofrecer a los hombres un mayor control sobre su fecundidad; sin embargo, algunos participantes plantearon sus preocupaciones sobre los efectos secundarios y consideraron que los hombres no usarían anticonceptivos. Las características de la relación, como las uniones polígamas, se mencionaron como posibles desafíos. En ambos países, se propusieron varios tipos de métodos anticonceptivos (por ejemplo, cremas o jaleas, la inyección y el implante) y de distintas duraciones (de acción corta a permanente). Conclusiones: La aceptabilidad de los nuevos métodos masculinos en la mayoría de los participantes en los dos países indica una demanda potencial de anticoncepción masculina. Las opciones deberían incluir una variedad de características del método para maximizar la elección, involucrar a los hombres y apoyar las necesidades de anticonceptivos de hombres y mujeres.RÉSUMÉ Contexte: Les options contraceptives masculines ne sont guère nombreuses. Le fait est, cependant, que les efforts de développement de produits se concentrent généralement sur les méthodes féminines. L'étude des attitudes à l'égard des méthodes masculines — en particulier dans les régions à faible prévalence contraceptive telles que l'Afrique subsaharienne — permettrait d'éclairer le développement de nouvelles méthodes pour les hommes. Méthodes: Les données qualitatives requises ont été extraites de discussions de groupe menées en 2016 avec 80 hommes âgés de 23 à 67 ans et 398 femmes âgées de 15 à 50 ans au Burkina Faso et en Ouganda. Elles ont été transcrites et analy-sées thématiquement pour examiner le soutien des hommes et des femmes à l'égard des méthodes contraceptives masculines et en dégager les suggestions possibles sur les caractéristiques des méthodes idéales. Résultats: Dans les deux pays, les participants et participantes ont exprimé leur appui de nouvelles options de contraception masculine; plus d'attitudes positives ont été exprimées en Ouganda qu'au Burkina Faso. Les participants des deux sexes ont reconnu que les méthodes masculines pourraient alléger la charge de la planification familiale portée par les femmes et offrir aux hommes un meilleur contrôle de leur fécondité. Certains s'inquiétaient cependant des effets secondaires et pensaient que les hommes n'utiliseraient pas les contraceptifs. Les caractéristiques de relation, telles que les unions polygames, ont été citées comme difficultés possibles. Dans les deux pays, différentes méthodes (par exemple, crèmes ou gels, injection ou implant) et durées (de courte à permanente) ont été proposées. Conclusions: L'acceptabilité de nouvelles méthodes masculines aux yeux de la plupart des participants dans les deux pays révèle une demande potentielle de contraception masculine. Les options proposées doivent inclure diverses caractéristiques de méthode pour maximiser le choix, engager les hommes et soutenir les hommes et les femmes dans leurs besoins contraceptifs.

Despite the availability of a variety of contraceptive methods, millions of women still have an unmet need for contraceptive choices. Short-acting methods are plagued by issues with adherence, leading to imperfect or inconsistent use and subsequent unintended pregnancy. Long-acting contraceptive methods such as intrauterine devices and contraceptive implants, while providing highly effective and safe contraception, do not meet the needs of all women, often due to cost, access or acceptability issues. Several new methods are in various stages of development and are designed to address the shortcomings of current methods. Providers should be aware of these future options and how they might better meet women's needs.

Background: Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. Methods: We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. Results: More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Conclusions: Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Use of contraceptive implants has surged in recent years, yet emerging data show a deficit of service delivery capacity and coverage for implant removals. The number of projected removals needed in the 69 FP2020 focus countries in 2018 (4.9–5.8 million) is more than twice that estimated for 2015 (2.2 million). We must proactively plan and execute high-quality implant removal services in order to fulfill the exceptional promise of implants in meeting client needs and advancing toward FP2020 goals.

CONTEXT: Unmet need for contraception has become a central concept in the family planning field and one of the most important indicators for program planning and evaluation. The measure has faced criticism however for not taking into account women’s stated intention to use contraceptives. METHODS: Using longitudinal data on more than 2500 rural Bangladeshi women in 128 villages this study links women’s contraceptive adoption and experience of unwanted pregnancy between 2006 and 2009 to their unmet need status and their stated intention to use contraceptives in 2006. RESULTS: Intention to use a method was predictive of subsequent use for both women with and without an unmet need. Three-quarters of the unintended pregnancies reported between 2006 and 2009 occurred among women without an unmet need in 2006. In addition nearly half of women without an unmet need who were pregnant or postpartum in 2006 had experienced an unwanted pregnancy compared with 30% of all women classified as having an unmet need. CONCLUSION: To adequately meet population family planning needs programs must look beyond unmet need and focus on the total demand for acceptable and effective methods.

Collecting contraceptive-use data by means of calendar methods has become standard practice in large-scale population surveys, yet the reliability of these methods for capturing accurate contraceptive histories over time remains largely unknown. Using data from overlapping contraceptive calendars included in a longitudinal study of 3,080 rural Bangladeshi women, we assessed the consistency of reports from the baseline interview month in 2006 with reports from the same month in a follow-up survey three years later, and examined predictors of reliable reporting. More than one-third of women were discordant in their reports for the reference month in the two surveys. Among women reporting use of any contraceptive method for the reference month in both surveys, 25 percent reported different methods at the two time points. Women using condoms or traditional methods and those with more complex reproductive histories, including more births and more episodes of contraceptive use, were least likely to report reliably. (STUDIES IN FAMILY PLANNING

Objectives Measuring the amount of progestin remaining in contraceptive implants used for different lengths of time provides useful information on in vivo release kinetics including change over time. We compared estimated in vivo levonorgestrel (LNG) release rates derived from Sino-implant (II) explants with similar data from removed Jadelle. Study design We measured LNG remaining in 44 sets of Sino-implant (II) used for up to 7 years and removed in four Chinese clinics. Results were compared with published data for Jadelle explants used for up to 36 months. We estimated and compared monthly and daily LNG release rates for the two products using prediction models for drug release. We also estimated the dissolution profile similarity factor, f 2 , for LNG release. Results Both Sino-implant (II) and Jadelle release approximately 30% of total LNG load after 3 years. Results of fitting the data to a biologically plausible modified Higuchi prediction model indicate comparable release through 3 years. An estimated similarity factor of 80.6 (90% confidence interval: 70.8–85.7) indicates similarity in the dissolution profiles of the two implants. Conclusions LNG release in vivo measured through explant analysis suggest that Sino-implant (II) and Jadelle may perform similarly through 3 years of use and could remain highly effective beyond this time point. These results align with published data for Jadelle and Sino-implant (II) showing high effectiveness for 5 years. Ongoing clinical studies comparing the products over 5 years present an opportunity to verify this supportive measure of clinical effectiveness. Implications This innovative approach provides evidence that Sino-implant (II) may perform clinically similarly to Jadelle over 3 years and remain a highly effective contraceptive beyond this time point. Data from explant analyses show promise for investigating the equivalence of elusion profiles of contraceptive implants.