CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE

CCTN - 避孕临床试验网络 - 核心 - 女性

• 批准号: 8261606
• 负责人: LIVIA WAN
• 金额: $ 9.34万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-31 至 2013-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8261606
• 关键词: Adverse effects; Advisory Committees; Age; Clinical; Clinical Trials; Clinical Trials Network; Conduct Clinical Trials; Consultations; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Data; Development; Devices; Dose; Drug Kinetics; Enrollment; Estradiol; Female; Female Contraceptive Agents; Goals; Gynecologic; Hemorrhage; Human Resources; Intervention; Male Contraceptive Agents; Methods; Mission; National Institute of Child Health and Human Development; Nestorone; Notification; Obesity; Pattern; Pharmaceutical Preparations; Phase; Population; Principal Investigator; Progestins; Protocols documentation; Public Health; Randomized; Research; Research Design; Risk; Risk Factors; Safety; Site; Specific qualifier value; Thromboembolism; Vaginal Ring; Venous; Woman; base; contraceptive effectiveness; contraceptive efficacy; drug candidate; programs; protocol development; reproductive; treatment trial; unintended pregnancy

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 use.

NICHD 的避孕临床试验网络对多种新型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 承包商开展女性避孕临床试验、妇科疾病治疗试验，并根据无限期交付/无限数量 (IDIQ) 合同制定任务订单的研究方案。 人们需要新的避孕方法，以有效防止意外怀孕，并降低静脉血栓栓塞 (VTE) 的风险，特别是对于肥胖女性。一种可以输送高剂量孕激素（Nestorone）和低剂量雌二醇（E2）的新型阴道环可以为女性提供有效且安全的避孕方法。剂量探索研究的目的是确定在长达 6 个月的使用时间内可以提供可靠避孕和可接受的出血模式的剂量。