Defining end-user preferences among US women to optimize the design of a long-acting injectable hormonal contraceptive

确定美国女性最终用户的偏好，以优化长效注射激素避孕药的设计

• 批准号: 10459006
• 负责人: DAVID R FRIEND
• 金额: $ 24.93万
• 依托单位: DARE BIOSCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459006
• 关键词: Address; Adherence; Age; Behavioral; Biological Sciences; Businesses; Characteristics; Clinic; Contraceptive Agents; Contraceptive Availability; Contraceptive History; Contraceptive methods; Cross-Sectional Studies; Data; Development; Devices; Dose; Effectiveness; Etonogestrel; Evaluation; Fertility; Formulation; Future; Hemorrhage; Heterogeneity; Hormones; Implant; Injectable; Intrauterine Devices; Light; Mechanics; Medroxyprogesterone 17-Acetate; Menstruation; Methods; Microspheres; Modeling; Oral Contraceptives; Pattern; Persons; Population; Pregnancy; Reproductive Health; Reproductive History; Research; Respondent; Sampling; Scientist; Surveys; Technology; Variant; Woman; age group; base; design; drug release kinetics; experience; experimental study; first-in-human; hormonal contraception; innovation; interest; phase I trial; preference; pregnant; prototype; recruit; response; rural residence; satisfaction; side effect; sociodemographics; uptake

PROJECT ABSTRACT Injectable hormonal contraception is an important part of the method mix globally, with depot medroxyprogesterone acetate (DMPA) the most commonly used injectable product. Many women find injectables more convenient and discreet than taking a daily birth control pill, and some prefer this method to device-based longer-acting reversible methods (e.g., intrauterine devices; implants). Although with ideal use DMPA is over 99% effective, several features have limited compliance and hence effectiveness, including barriers/inconvenience associated with returning to the clinic every three months, side effects/menstrual pattern changes, and long/unpredictable return to fertility. In fact, one- year continuation rates can be as low as 40%. Daré Bioscience is developing a long-acting injectable (LAI) that provides extended release of etonogestrel with precise control over drug release rate, targeting windows of protection for six months and 12 months, a rapid return of fertility within two months, a steadier hormone dose than currently available therapies, and anticipated side effects similar to Nexplanon® (the currently-approved method of delivering etonogestrel). End-user research is critical for designing an LAI that users will find acceptable, to increase the likelihood of future uptake and consistent use. This R43 study, conducted in partnership with the Population Council, comprises end- user research with US women to understand their preferences for LAI duration in light of other attributes (particularly effect on menstruation, side effects, and return to fertility), acceptability of the LAIs vs. other contraceptive methods, and heterogeneity in duration preferences and acceptability between different end-user profiles. We will leverage Amazon’s Mechanical Turk (MTurk) platform to efficiently survey a national sample of 1,000 women ages 18-44 years, stratified by age group, urban/rural residence, and ever-use of hormonal contraception. In Aim 1, we will examine women’s LAI duration preferences, considering other product attributes, by implementing a discrete choice experiment (DCE), as well as acceptability of the LAIs compared with currently available contraceptive methods. In Aim 2, we will identify distinct LAI end-user profiles via latent class analyses (LCA), and LAI duration preferences for each. LCA models will include end users’ overall perceived acceptability of the LAIs, socio-demographic characteristics, fertility intentions, reproductive history, and contraceptive history/general preferences. Findings from this study will directly inform which LAI duration(s) to pursue and identify the characteristics of US women most likely to be interested in using an LAI. If this R43 study is successful, as defined by confirmation of hypotheses that the LAI would fill unmet contraceptive needs, we will pursue an evaluation of end-user experiences using our selected LAI prototype(s) within the first in-human Phase I trial of an LAI.

项目摘要 注射激素避孕药是全球避孕方法的重要组成部分，长效制剂 醋酸甲羟孕酮 (DMPA) 是许多女性最常用的注射产品。 注射剂比每日服用避孕药更方便、更谨慎，有些人更喜欢这种方法 方法到基于装置的长效可逆方法（例如宫内节育器；植入物）。 尽管在理想的使用情况下 DMPA 的有效性超过 99%，但一些功能的合规性有限，并且 因此，有效性，包括每三年返回诊所相关的障碍/不便 几个月、副作用/月经模式变化以及长期/不可预测的生育能力恢复事实上，一-。 年持续率可低至 40% Daré Bioscience 正在开发一种长效注射剂。 （LAI）可延长依托孕烯的释放，并精确控制药物释放速率， 目标是六个月和十二个月的保护窗口，在两年内迅速恢复生育能力 几个月，比目前可用的疗法更稳定的激素剂量，以及类似的预期副作用 Nexplanon®（目前批准的依托孕烯给药方法）最终用户研究至关重要。 设计用户会接受的 LAI，以增加未来采用的可能性，以及 这项 R43 研究是与人口理事会合作进行的，包括最终结果： 对美国女性进行用户研究，根据其他属性了解她们对 LAI 持续时间的偏好 （特别是对月经、副作用和恢复生育能力的影响），LAI 与 LAI 的可接受性 其他避孕方法，以及不同避孕方法之间的持续时间偏好和可接受性的异质性 我们将利用亚马逊的 Mechanical Turk (MTurk) 平台来高效地处理不同的最终用户资料。 对全国 1,000 名 18-44 岁女性样本进行调查，按年龄组、城市/农村进行分层 在目标 1 中，我们将检查女性的 LAI 持续时间。 偏好，考虑其他产品属性，通过实施离散选择实验（DCE）， 以及与目前可用的避孕方法相比 LAI 的可接受性。在目标 2 中， 我们将通过潜在类别分析 (LCA) 和 LAI 持续时间来识别不同的 LAI 最终用户概况 每个 LCA 模型的偏好将包括最终用户对 LAI 的整体感知可接受性， 社会人口特征、生育意愿、生育史和避孕措施 本研究的结果将直接告知要追求的 LAI 持续时间。 并确定最有可能对使用 LAI 如果此 R43 感兴趣的美国女性的特征。 研究是成功的，定义为确认 LAI 将填补未满足的避孕措施的假设 需求，我们将使用我们选定的 LAI 原型对最终用户体验进行评估 LAI 的首次人体 I 期试验。