Prophylactic Ibuprofen: Effect on IUD Continuation Rates

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， 避孕妇女使用它们。使用量的迅速下降部分是由于 对市场上不再销售的设备的安全性担忧。小于 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吸引新的用户群体， 如果某些不利的方法特定的功能可以减轻。 出血和疼痛增加是宫内节育器使用者最常见的抱怨; 这两种副作用加在一起会导致高达15%的女性停药 第一年内使用。IUD通常用于治疗IUD引起的 出血和疼痛，虽然它不是常规提供的时候， 插入或作为带回家的药物。如果新用户服用布洛芬之前， 插入并提供布洛芬带回家，他们可能会避免 否则可能会导致早期移除的不适。主要目的 这项研究的目的是确定预防性使用布洛芬是否会影响 续用率。该研究还将衡量布洛芬对人体的影响 取出IUD的原因分布、出血和疼痛次数 事件和计划外门诊访视的数量。这是一项双盲 2,258例首次使用IUD者的随机对照试验; 参与者将接受布洛芬，另一半将接受 看起来一模一样的安慰剂女性将在45分钟内接受第一次注射 并要求在3-5天内服用相同的药物， 接下来的六个月经周期虽然干预部分， 这项研究只持续了六个月，两组妇女将被随访， 比较12个月的总体停药率， 取出、插入时疼痛程度、插入后出血发生率和 疼痛事件和计划外门诊访视次数。如果发现布洛芬 为了对继续率产生有益的影响，它可以成为一种标准， 产品标签的特点;因为布洛芬是廉价，安全， 它可以在非处方药中容易获得，最终可以改善IUD 为全球1亿女性提供舒适。在美国，布洛芬可能有助于刺激 重新关注最具成本效益和有效的可逆 提供避孕方法。

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.