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: 9149743
• 负责人: CAROLYN L WESTHOFF
• 金额: $ 35.84万
• 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 2018-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9149743
• 关键词: Adverse effects; Age; Child; Child health care; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Copper; Copper Intrauterine Devices; Data; Development; Devices; Dose; Effectiveness; Ethinyl Estradiol; Evaluation; Hemorrhage; Hormonal; Hormones; Human Development; Implant; Incidence; Institutes; 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; novel; prospective; reproductive; 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).

“ Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）”下的避孕发现与发展分支（CDDB）致力于开发新方法，这些方法是长期行动可逆的避孕药（LARC），这些方法可以为某些避孕产物以及危险的危险因素提供安全有效避孕的妇女，以及危险的危险因素，以及危险的危险。具有长效避孕益处的内在系统的示例，而无需外源恐怖或普通月经的破坏。 LARC方法包括宫内节育器，即兴或长期表演的阴道环。 LARC方法比每日，每周或每月产品更有效，因为它们不易用用户错误。宫内节育器和即兴的有效率是典型使用的最高级别（> 99％效率）。开发新的LARC方法是CDDB的高度优先级。 在当前批准的LARC方法中，含铜的宫内节育器是唯一的不涉及激素且不会引起女性不规则或未进行的出血模式的唯一非常有效的可逆方法。对于不希望服用或不能采用荷尔蒙避孕方法的女性，这些特性使宫内节育器成为理想的方法。含有合成雌激素和乙基雌二醇的产品与VIE的剂量依赖性增加有关。铜宫内节育器不会增加VTE的风险，因此适合使用VTE风险增加的妇女，例如肥胖妇女，孕妇和莱顿因子V的妇女。该宫内节育器与插入的疼痛以及随后几个月的使用时发生了高的入射痉挛和大量出血有关。停用该方法的第一原因是与设备相关的重量出血和痉挛的事件。一些研究的初步数据表明，较新的铜宫内节育器可能与较低的出血和/或抽筋的发生率较低有关，并且某些设备的插入可能会减少疼痛。目前尚不清楚某些妇女人群中是否有任何新设备的开除率较低。 为了评估新的LARC产品是否可以有效避孕，并且可能导致中断的副作用较低，将在NICHD避孕临床试验网络（CCTN）中进行前瞻性随机对照临床试验。如上所述，提议测试的产品是LARC。这些产品将与当前可用的LARC方法进行比较。 拟议的研究将在生殖年龄的女性中进行，以评估避孕效率，插入疼痛，出血模式，助理痉挛，驱逐率以及长期可逆避孕药（LARCS）的其他安全和副作用。