CCTN-CLINICAL EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION

NICHD的避孕临床试验网络对各种新的女性和男性避孕方法进行第一、第二和第三阶段的临床试验。该合同的目的是让CCTN承包商进行女性避孕临床试验，进行妇科疾病的治疗试验，并根据不确定交付/不确定数量（IDIQ）合同，以任务订单为基础制定研究方案。 为了降低静脉血栓栓塞（VTE）的风险，特别是肥胖妇女，需要无雌激素避孕。本文报道了一种新的丁酸左炔诺孕酮（LB）长效注射剂。左炔诺孕酮（LNG）在各种避孕药（避孕药、宫内节育器和植入物）中的临床应用历史悠久，其有效性和安全性得到了广泛认可。CCTN将根据PK研究的结果选择剂量进行LB的剂量探索研究，该研究正在俄勒冈州健康与科学大学根据任务订单进行。

The NICHD's Contraceptive Clinical Trials network conducts Phase I, II and III clinical trials of a wide variety of new female and male contraceptive methods. The objective of this contract is for CCTN contractors to conduct female contraceptive clinical trials, conduct treatment trials of gynecologic conditions, and to develop research protocols on a task Order basis under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. There is a demand for estrogen-free contraception in order to reduce the risk of venous thromboembolism (VTE), particularly of obese women. A new 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 are well recognized. The CCTN will conduct a dose finding study of LB with doses selected on the basis of the results from the PK study, which is being conducted under a task order at Oregon Health and Science University.