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

丁酸左炔诺孕酮用于女性避孕的 CCTN-药代动力学/药效学评价

• 批准号: 10497859
• 负责人: STEPHANIE TEAL
• 金额: $ 11.52万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/10497859
• 关键词: Adherence; Age; Body mass index; Clinical; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Data; Drug Kinetics; Enrollment; Estrogens; Evaluation; Female Contraceptive Agents; Formulation; Free Will; Implant; Injectable; Injections; Intramuscular; Intrauterine Devices; Ions; Lactation; Levonorgestrel; Mission; National Institute of Child Health and Human Development; Non obese; Obesity; Pharmacodynamics; Population; Progestins; Public Health; Recording of previous events; Regimen; Risk; Route; Safety; Time; United States Food and Drug Administration; Woman; contraceptive efficacy; pharmacokinetics and pharmacodynamics; pill; recruit; reproductive; subcutaneous; venous thromboembolism

There is a demand for estrogen-free contraception m order to reduce the risk of venous thromboembolism (VTE), particularly for obese women . A ne,., long-acting formulation 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 arc well recognized. The Eunice KenJ1edy 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 tl1e 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 inject able 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 VTC 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 m \\Omen 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 inject ion. The Recruitment will include enrollment of approximately 50% of subjects with BMI >=32 kg/m2 but less than 40 kg/m2

为了降低静脉血栓栓塞 (VTE) 的风险，尤其是肥胖女性，需要无雌激素避孕药。一种新的、长效的丁酸左炔诺孕酮 (LB) 注射剂已被开发出来。左炔诺孕酮 (LNG) 在各种避孕药具（药丸、宫内节育器和埋植剂）中有着悠久的临床应用历史，其功效和安全性得到了广泛认可。 Eunice KenJ1edy Shriver 国家儿童健康和人类发展研究所 (NICHD) 的使命是为女性（包括肥胖女性）开发安全有效的避孕药具。肥胖是美国人口面临的头号公共卫生问题，也是静脉血栓栓塞 (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方法，且不会增加 VTE 的风险。 美国食品和药物管理局 (FDA) 批准的一种避孕方法是纯孕激素避孕药 (POP) 或所谓的“迷你避孕药”，主要供哺乳期妇女使用，只能使用几个月，并且需要严格遵守在每天同一时间。一种长效 不含雌激素的 LB 注射剂将提供比 POP 更容易遵循的治疗方案，并且理论上具有较低的 VTC 风险，特别是对于肥胖女性。 为了提供 LB 可以有效避孕的初步证据，一项临床研究试验将在 NICHD 避孕临床试验网络 (CCTN) 中进行。 拟议的研究将在育龄期进行，以评估这种新药物的药代动力学、避孕功效机制和安全性。 避孕药。登记的受试者将通过肌内和皮下注射途径接受LB。此次招募将包括大约 50% 具有 BMI 的受试者的招募 >=32 kg/m2 但小于 40 kg/m2