CCTN-CLINICAL EVALUATION OF NESTORONE/ESTRADIOL-RELEASING RING FOR FEMALE

CCTN-女性雌激素释放环的临床评估

• 批准号: 8261602
• 负责人: MITCHELL CREININ
• 金额: $ 56.07万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 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/8261602
• 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; research clinical testing; 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。 需要新的避孕方法，可以提供有效的保护，防止意外怀孕，并减少静脉血栓栓塞（VTE）的风险，特别是对肥胖妇女。一种新的阴道环，可以提供高剂量的炔雌醇（Nestorone）和低剂量的雌二醇（E2），可以为妇女提供有效和安全的避孕。剂量探索研究的目的是确定可提供可靠避孕和可接受出血模式长达6个月使用的剂量。