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I、II和III期临床试验。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）合同在任务订单的基础上制定研究方案。

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.