Prophylactic Ibuprofen: Effect on IUD Continuation Rates

预防性布洛芬：对宫内节育器继续使用率的影响

• 批准号: 6526411
• 负责人: DAVID HUBACHER
• 金额: $ 28.55万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-25 至 2004-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6526411
• 关键词: behavioral /social science research tag; chemoprevention; clinical trials; health behavior; human subject; human therapy evaluation; ibuprofen; nondrug contraceptive; outcomes research; pain; patient oriented research; women's health

DESCRIPTION (provided by applicant): Intrauterine devices (IUDs) were once a very popular birth control method in the US; in the 1970s, nearly ten percent of contracepting women used them. The rapid decline in use is due in part to the safety concerns about devices that are no longer on the market. Less than one percent of US women use today's IUDs, yet there is great potential for attracting a new population of users if the negative image of past devices can be shed and if certain unfavorable method-specific features can be mitigated. Increased bleeding and pain are the most common complaints of IUD users; together these two side effects cause up to 15 percent of women to discontinue use within the first year. Ibuprofen is commonly used to treat IUD-induced bleeding and pain, though it is not routinely provided either at the time of insertion or as a take-home medication. If new users take ibuprofen before insertion and are given a supply of ibuprofen to take home, they may avoid discomforts that might otherwise lead to early removal. The primary objective of this study is to determine whether prophylactic use of ibuprofen affects continuation rates. The study will also measure the impact ibuprofen has on the distribution of reasons for IUD removal, the number of bleeding and pain events, and the number of unscheduled clinic visits. This is a double-blind randomized controlled trial of 2,258 first-time IUD users; half of the participants will receive ibuprofen and the other half will receive an identical-appearing placebo. Women will be given their first dose 45 minutes prior to insertion and asked to take the same medication over the 3-5 days of menses for each of their next six cycles. Though the intervention component of the study lasts only six months, the two groups of women will be followed up for twelve months to compare overall discontinuation rates, reasons for removal, level of pain at insertion, incidence of post-insertion bleeding and pain events, and the number of unscheduled clinic visits. If ibuprofen is found to have a beneficial effect on continuation rates, it can become a standard feature of product labeling; because ibuprofen is inexpensive, safe, and readily available in over-the-counter form, it could ultimately improve IUD comfort for 100 million women worldwide. In the US, ibuprofen may help spur renewed interest in the most cost effective and efficacious reversible contraceptive method available.

描述(由申请人提供)：宫内节育器(IUD)曾经是 在美国非常流行的节育方法；在20世纪70年代，近10% 使用避孕药的女性。使用量迅速下降的部分原因是 对市场上不再存在的设备的安全担忧。少于 1%的美国妇女使用今天的宫内节育器，但有很大的潜力 如果过去设备的负面形象可以 如果某些不利的方法特定的特征可以减轻。 宫内节育器使用者最常抱怨的是出血增多和疼痛； 这两种副作用加在一起会导致高达15%的女性停止生育 在第一年内使用。布洛芬常用于治疗宫内节育器 出血和疼痛，尽管它不是常规提供的，在 或者作为一种带回家的药物。如果新使用者以前服用布洛芬 并给予布洛芬供应带回家，他们可能会避免 否则可能会导致提早移除的不适。首要目标是 这项研究的目的是确定预防性使用布洛芬是否会影响 续订率。这项研究还将衡量布洛芬对 取出宫内节育器的原因、出血和疼痛的分布 活动，以及计划外诊所就诊的次数。这是一种双盲 对2258名首次使用宫内节育器的人进行的随机对照试验； 参与者将获得布洛芬，另一半将获得 看起来一模一样的安慰剂。女性将被给予45分钟的第一剂疫苗 在插入之前，并要求在3-5天内服用相同的药物 在接下来的六个周期中每一个周期的月经。虽然干预部分是 这项研究只持续6个月，将对两组女性进行随访 12个月来比较总体停用率，原因是 拔除、插入时的疼痛程度、插入后出血的发生率和 疼痛事件，以及计划外诊所就诊的次数。如果发现布洛芬 为了对续订率产生有益的影响，它可以成为一种标准 产品标签的特点；因为布洛芬便宜，安全， 它以非处方药的形式现成，最终可能会改善宫内节育器 为全球1亿女性提供慰藉。在美国，布洛芬可能有助于刺激 对最具成本效益和最有效的可逆产品重新产生兴趣 提供避孕方法。