Copper Intravaginal Contraception

铜阴道内避孕

基本信息

批准号：
10018526
负责人：
Cheryl Katherine Walker
金额：
$ 32.83万
依托单位：
UNIVERSITY OF CALIFORNIA AT DAVIS
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-15 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10018526
关键词：
3-Dimensional Animals Bacteria Barrier Contraception Biomedical Engineering Biometry Blood Breast Cancer Risk Factor Breast Feeding Buffers Cells Cervical Cervix Mucus Chronic Clinical Communication Complex Contraceptive Agents Contraceptive Devices Contraceptive Usage Contraceptive methods Copper Copper Intrauterine Devices Country Couples Development Dose Effectiveness Engineering Environmental Engineering technology Epithelial Epithelial Cells Epithelium Failure Family Planning Female Film Formulation HIV HIV Infections Hemorrhage Hormonal Hormones Human In Vitro Infant Inflammatory Intake Ions Kinetics Laboratories Lactation Lactobacillus Liquid substance Macaca mulatta Male Genital Organs Mammals Measures Menstrual cycle Methods Milk Modeling Mothers Mus Muscle Cramp Organism Phase Polymers Postpartum Period Pregnancy Rate Prevention Primates Probability Process Property Reaction Research Project Grants Resource Sharing Resources Risk SIV Safety Science Sexual Transmission Sexually Transmitted Diseases Sperm Motility Standardization Surface System Technology Testing Thromboembolism Thrombosis Time Tissues Toxic effect Toxicity Tests Training Vagina Vaginal Ring Woman Work antimicrobial collaborative environment contraceptive effectiveness contraceptive microbicide cost cytotoxic cytotoxicity effectiveness testing experience experimental study hormonal contraception in vitro Assay in vivo innovation interest member microbicide migration nonhuman primate novel pathogen phthalocyanine prevent product development prototype reproductive reproductive tract research clinical testing reversible contraceptive safety testing side effect sperm cell steroid hormone unintended pregnancy vaginal fluid vaginal microbiome virology

项目摘要

ABSTRACT – Copper Vaginal Contraception Unintended pregnancy rates in the U.S., as well as in many countries around the world, remain unacceptably high. Many women are reluctant to use hormonal contraceptives due to concerns about thromboembolism, irregular vaginal bleeding, or other side effects. Existing hormone-free contraceptive options that are reversible include barrier methods which typically have relatively high failure rates, and copper intrauterine contraceptives – which require placement by a trained clinician and often increase menstrual bleeding and cramping. Thus, new contraceptive options are needed. A woman-controlled contraceptive that is more effective than existing barrier contraceptives and could be initiated without a clinician's assistance would be of great benefit in many settings; especially if a single contraceptive device could be used for an extended period of time and could simultaneously reduce risks of sexually transmitted infection as a multi-purpose prevention technology. The proposed research project will develop a copper intravaginal contraceptive product that may also reduce risk for acquisition of sexually transmitted infections. In-vitro experiments in the R61 phase of the work will guide product development in an iterative process. The safety and effectiveness testing planned for the R33 phase will employ a non-human primate model that is well-established for contraceptive development. Sub- aims will serve as targets, and product fabrication and contraceptive effectiveness will be the primary milestones of the R61 and R33 phases, respectively. Over the 5-year project, we will hone prototypes for long- and short-acting versions of an exciting and innovative female-controlled, non-hormonal copper vaginal contraceptive method that will be suitable for Phase I human clinical testing.

摘要 – 铜阴道避孕药美国以及世界许多国家的意外怀孕率仍然令人无法接受由于担心血栓栓塞，许多女性不愿意使用激素避孕药，不规则阴道出血或其他可逆的现有无激素避孕选择。包括通常失败率相对较高的屏障方法和含铜宫内避孕药 – 需要由训练有素的临床医生放置，并且经常会增加月经出血和痉挛。需要一种比现有避孕方法更有效的女性自控避孕方法。屏障避孕药可以在没有临床医生帮助的情况下开始使用，这对许多人来说是有很大好处的设置；特别是如果可以长时间使用单一避孕器具并且可以作为一种多用途的预防技术，同时降低性传播感染的风险。拟议的研究项目将开发一种铜阴道内避孕产品，该产品也可能减少 R61 阶段的体外实验将降低获得性传播感染的风险。指导 R33 的安全性和有效性测试的迭代过程。该阶段将采用一种为避孕药开发而完善的非人类灵长类动物模型。以目标为目标，以产品制造和避孕效果为首要 R61 和 R33 阶段的里程碑在为期 5 年的项目中，我们将磨练长期的原型。以及令人兴奋和创新的女性控制的非激素铜阴道剂的短效版本适合I期人体临床试验的避孕方法。