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国家儿童健康和人类发展研究所（NICHD）的避孕药具发现和开发分支（CDDB）致力于开发长效可逆避孕药（LARC）的新方法，为可能存在某些避孕产品风险因素的妇女提供安全有效的避孕措施，并降低静脉血栓栓塞（VIE）的风险。 铜宫内节育器（IUD）是宫内系统的例子，提供长效避孕的好处，没有外源性激素或中断正常的月经周期。 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、每周或每月的产品更有效，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（>99%有效率）。 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高效的可逆方法，不涉及激素给药，不会导致女性不规则或计划外出血模式。 这些特性使铜宫内节育器成为不希望或不能采取激素避孕方法的妇女的理想方法。含有合成雌激素和炔雌醇的产品与VIE的剂量依赖性增加有关。 含铜宫内节育器不会增加静脉血栓栓塞的风险，因此适用于静脉血栓栓塞风险增加的女性，如肥胖女性、孕妇和莱顿因子V患者。 目前在美国有一种铜IUD，铜T380（Paragard®）。 这种宫内节育器与插入时的疼痛有关，并且在随后的几个月使用期间，痉挛和大量出血的发生率很高。停止该方法的首要原因是与该装置相关的严重出血和痉挛的发生率。 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严重出血和/或痉挛的发生率有关，一些装置可能具有较少的插入疼痛。目前还不清楚是否有任何新的设备可以有一个较低的发生率驱逐在某些人群的妇女。 为了评估新的LARC产品是否可以有效避孕，并且可能导致停药的副作用发生率较低，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。拟供试产品为上述LARC。这些产品将与目前可用的LARC方法进行比较。 拟议的研究将在育龄妇女中进行，以评价长效可逆避孕药（LARC）的避孕效果、插入疼痛、出血模式、相关痉挛、排出率以及其他安全性和副作用。