CCTN - PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION

CCTN - 丁酸左炔诺孕酮用于女性避孕的药代动力学/药效学评价

• 批准号: 10497855
• 负责人: CAROLYN L WESTHOFF
• 金额: $ 11.12万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-28 至 2023-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10497855
• 关键词: Adherence; Age; Body mass index; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contractor; Data; Development; Dose; Drug Kinetics; Enrollment; Estrogens; Evaluation; Female Contraceptive Agents; Free Will; Goals; Good Clinical Practice; Government; Implant; Injectable; Injections; International; Intramuscular; Intrauterine Devices; Lactation; Levonorgestrel; Mission; Monitor; National Institute of Child Health and Human Development; Non obese; Obesity; Pharmacodynamics; Population; Progestins; Protocols documentation; Public Health; Recording of previous events; Records; Regimen; Regulation; Risk; Route; Safety; Time; United States Food and Drug Administration; Woman; contraceptive efficacy; follow-up; pill; protocol development; recruit; reproductive; subcutaneous; symposium; venous thromboembolism

There is a demand for estrogen-free contraception in order to reduce the risk of venous thromboembolism (VTE), particularly for obese women. A new long-acting 􀁸ormulation of levonorgestrel butanoate (LB) delivered by injection has been developed. Levonorgestrel (LNG) has a long history of clinical use in a variety of contraceptives (pills, intrauterine devices, and implants) and its efficacy and safety are well recognized. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women, including obese women. Obesity is the number one public health issue facing the US population and is an independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to develop effective contraception for obese woman that does not increase the risk of VTE. One Food and Drug Administration (FDA) -approved contraceptive method is the progestin-only pill (POP) or so-called "mini pill," which is used mainly by lactating women only for several months and requires strict adherence to taking the POP at the same time every day. A long-acting injectable form of LB that is estrogen-free will provide a regimen that is easier to follow than a POP and have a theoretically lower risk of VTE especially for obese women. In order to provide preliminary evidence that LB could be effective for contraception, a clinical trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The proposed study will be conducted in women of reproductive age in order to evaluate pharmacokinetics, the mechanisms of contraceptive efficacy, and safety of this new contraceptive. The enrolled subjects will receive LB via intramuscular and subcutaneous routes of injection. The Recruitment will include enrollment of approximately 50% of subjects with BMI >=32 kg/m2 but less than 40 kg/m2

为了降低静脉的风险，有无雌激素的避孕需求 血栓栓塞（VTE），特别是对于肥胖女性。新的长效◎ 已经开发了注射剂（LB）的左甲虫（LB）。左甲虫（LNG） 在各种避孕药（药丸，内存设备和 即兴）及其有效性和安全性得到广泛认可。 Eunice Kennedy Shriver国家儿童健康与人类发展研究所 （NICHD）的使命是为包括肥胖在内的妇女开发安全有效的避孕药 女性。肥胖是美国人口面临的第一公共卫生问题，是 静脉血栓栓塞（VTE）的独立风险。因此，公共卫生需要 为肥胖女性开发有效的避孕，而肥胖女性不会增加VTE的风险。一 食品和药物管理局（FDA） - 批准的避孕方法是仅孕激素的药丸 （pop）或所谓的“迷你药”，主要是通过哺乳女性使用几个月 并且需要严格的依从性每天同时吸引流行音乐。长效 无雌激素的LB的注射形式将提供一种比一个更容易遵循的方案 POP，并且对VTE的理论风险较低，尤其是对于肥胖女性。为了提供 LB可以有效避孕的初步证据，临床试验将是 在NICHD避孕试验网络（CCTN）中进行。 拟议的研究将在生殖年龄的妇女中进行，以评估 药代动力学，避孕效率的机制以及这种新的安全性 避孕。注册受试者将通过肌肉内和皮下途径接受LB 注射。招聘将包括大约50％的BMI受试者入学 > = 32 kg/m2，但小于40 kg/m2