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

为了减少静脉血栓的风险，需要无雌激素避孕。 血栓栓塞（VTE），特别是肥胖女性。一种新的长效制剂􀁸 已开发了通过注射递送的丁酸左炔诺孕酮（LB）。左炔诺孕酮（LNG） 在各种避孕药（避孕药、宫内节育器和 植入物）及其有效性和安全性是公认的。 尤妮斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所 （NICHD）的使命是为妇女，包括肥胖妇女，开发安全有效的避孕药具。 妇女肥胖是美国人口面临的头号公共健康问题， 静脉血栓栓塞（VTE）的独立风险。因此，公共卫生需要 为肥胖妇女开发有效的避孕方法，不会增加静脉血栓栓塞的风险。一 美国食品和药物管理局（FDA）批准的避孕方法是孕激素药丸 (POP)也就是所谓的“迷你药丸”，主要由哺乳期妇女使用， 并要求严格坚持每天在同一时间服用POP。长效 不含雌激素LB的可注射形式将提供一种比常规LB更容易遵循的方案， 从理论上讲，特别是对于肥胖女性来说，静脉血栓栓塞的风险较低。以此为您提供 有初步证据表明LB可以有效避孕，一项临床试验将在 NICHD避孕临床试验网络（CCTN）。 拟在育龄妇女中进行研究，以评价 药物动力学，避孕效果的机制，和安全性，这种新的 避孕药入组的受试者将通过肌内和皮下途径接受LB， 注射招募将包括入组约50%的BMI受试者 >=32 kg/m2但小于40 kg/m2