CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION: EFFICACY STUDY

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。有一种新的避孕方法的需求，可以提供有效的保护，防止意外怀孕，并降低静脉血栓栓塞（VTE）的风险，特别是对肥胖妇女。一种新的阴道环可以提供高剂量的黄体酮（Nestorone）和低剂量的雌二醇（E2），可能为女性提供有效和安全的避孕。这项剂量发现研究的目的是确定一个剂量，可以提供可靠的避孕和可接受的出血模式长达6个月的使用。拟议的研究将评估奈斯托酮和雌二醇环对女性的避孕功效、药代动力学、出血模式、安全性和副作用。

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 new methods of contraception that can provide effective protection against unintended pregnancy as well as reduce the risk of venous thromboembolism (VTE), particularly for obese women. A new vaginal ring that can deliver a high dose progestin (Nestorone) and a low dose of estradiol (E2) may provide effective and safe contraception for women. The objective of the dose finding study is to identify a dose that can provide reliable contraception and acceptable bleeding patterns for up to 6 months of useThe proposed study will evaluate contraceptive efficacy , pharmacokinetics, bleeding patterns and safety and side effects of a Nestorone & estradiol ring for women.