CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - EVALUATION REVERSIBLE CONTRACEPTIVE

CCTN - 避孕临床试验网络 - 评估可逆避孕药

• 批准号: 9923499
• 负责人: CAROLYN L WESTHOFF
• 金额: $ 29.08万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-25 至 2022-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9923499
• 关键词: Age; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Copper; Copper Intrauterine Devices; Data; Development; Devices; Dose; Effectiveness; Ethinyl Estradiol; Evaluation; Hemorrhage; Hormones; Implant; Incidence; Intrauterine Devices; Lead; Menstrual cycle; Methods; Muscle Cramp; National Institute of Child Health and Human Development; Obesity; Pain; Pattern; Population; Pregnant Women; Property; Randomized Controlled Clinical Trials; Risk; Risk Factors; Safety; Testing; Thromboembolism; Vaginal Ring; Venous; Woman; contraceptive effectiveness; contraceptive efficacy; factor V Leiden; hormonal contraception; novel; prospective; reproductive; reversible contraceptive; side effect; xenoestrogen

The Contraceptive Discovery and Development Branch (CDDB) under" the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is committed to develop new methods that are long-acting reversible contraceptives (LARCs) that can provide safe and effective contraception for women who may have risk factors against some contraceptive products as well as reduce the risk of venous thromboembolism (VIE). The copper intrauterine devices (IUDs) are examples of intrauterine systems that provide long-acting contraceptive benefits without exogenous hormones or disruption of the regular menstrual cycle. LARC methods include IUDs, implants, or long acting vaginal rings. LARC methods are more effective than daily, weekly or monthly products because they are less prone to user error. IUDs and implants have an effectiveness rate that is in the top tier for typical use (>99% effective). Development of new LARC methods is a high priority for the CDDB. Of the currently approved LARC methods, copper-containing IUDs are the only highly effective reversible methods that do not involve administration of hormones and do not cause irregular or unscheduled bleeding patterns in women. These properties make a copper IUD an ideal method for women who do not wish to take or cannot take hormonal contraceptive methods. Products containing the synthetic estrogen and ethinyl estradiol have been associated with a dose-dependent increase in VIE. Copper IUDs do not increase the risk of VTE and would therefore be suitable for use by women who have an increased risk ofVTE, such as obese women, pregnant women and women with Leiden Factor V. Currently there is one copper IUD, Copper T380 (Paragard®), available in the US. This IUD is associated with pain on insertion and with a high incidence cramping and heavy bleeding during subsequent months of use. The number one reason for discontinuation of the method is the incidence ofheavy bleeding and cramping associated with the device. Preliminary data from some studies indicate that newer copper IUDs may be associated with a lower incidence of heavy bleeding and/or cramping and some devices may have less pain with insertion. It is unclear if any of the newer devices could have a lower incidence of expulsion in some populations of women. In order to evaluate if new LARC products could be effective for contraception, and have a lower incidence of side effects that might lead to discontinuation, a prospective randomized controlled clinical trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The products proposed to be tested are LARCs as described above. These products will be compared to the currently available LARC methods. The proposed study will be conducted in women of reproductive age in order to evaluate contraceptive efficacy, pain of insertion, bleeding patterns, associate cramping, expulsion rates as well as other safety and side effects of the long-acting reversible contraceptives (LARCs).

尤尼斯·肯尼迪·施莱弗国家儿童健康与人类发展研究所(NICHD)下的避孕发现和发展处(CDDB)致力于开发长效可逆避孕药(LARC)的新方法，为可能对某些避孕产品有危险因素的女性提供安全有效的避孕措施，并降低静脉血栓栓塞症(VIE)的风险。铜质宫内节育器(IUD)是宫内系统的例子，它提供长效的避孕益处，而不需要外源性激素或扰乱正常的月经周期。 LARC方法包括宫内节育器、植入物或长效阴道环。LARC方法比每日、每周或每月产品更有效，因为它们不太容易出现用户错误。宫内节育器和植入物的有效率在典型使用中处于最高水平(&gt；99%有效)。开发新的LARC方法是CDDB的高度优先事项。 在目前批准的LARC方法中，含铜宫内节育器是唯一一种高度有效的可逆方法，不涉及激素管理，也不会导致妇女不规则或计划外出血模式。这些特性使铜质宫内节育器成为不愿或不能采取激素避孕方法的女性的理想方法。含有合成雌激素和乙烯基雌二醇的产品与VIE的剂量依赖性增加有关。铜质宫内节育器不会增加患VTE的风险，因此适合那些VTE风险增加的女性使用，例如肥胖妇女、孕妇和患有莱顿因子V的妇女。目前，美国有一种铜质IUD，即铜T380(Paragard®)。这种宫内节育器在放置时会出现疼痛，在接下来的几个月中会出现高发生率的抽筋和大出血。停止该方法的首要原因是与该设备相关的大出血和抽筋的发生率。一些研究的初步数据表明，较新的铜质宫内节育器可能与大出血和/或抽筋的发生率较低有关，一些装置可能在放置时疼痛较轻。目前尚不清楚是否有任何较新的装置可以在某些女性群体中降低驱逐的发生率。 为了评估新的LARC产品是否可以有效地避孕，并降低可能导致停用的副作用的发生率，NICHD避孕临床试验网络(CCTN)将进行一项前瞻性随机对照临床试验。建议测试的产品是上文所述的LARC。这些产品将与目前可用的LARC方法进行比较。 这项拟议的研究将在育龄妇女中进行，以评估长效可逆避孕药(LARC)的避孕效果、插入疼痛、出血模式、相关抽筋、排出率以及其他安全性和副作用。