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)合同按任务顺序制定研究方案。人们需要新的避孕方法，既能有效防止意外怀孕，又能降低静脉血栓栓塞症(VTE)的风险，特别是对肥胖妇女来说。一种可以提供高剂量孕激素(雀巢)和低剂量雌二醇(E2)的新型阴道环可能为女性提供有效和安全的避孕措施。剂量发现研究的目的是确定一种可以提供可靠避孕和可接受的出血模式长达6个月的剂量。拟议的研究将评估女性使用的雌酮-雌二醇环的避孕效果、药代动力学、出血模式以及安全性和副作用。

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.