Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; the Department of Obstetrics and Gynecology, David Geffen School of Medicine, Los Angeles, California; Health Decisions, Durham, North Carolina; the Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania; and Sebela Pharmaceuticals, Roswell, Georgia.
Obstet Gynecol. 2020 Apr;135(4):840-847. doi: 10.1097/AOG.0000000000003756.
To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator.
Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns.
A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06-1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0-3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13.
The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial.
ClinicalTrials.gov, NCT02446821.
Sebela Pharmaceuticals, Inc.
评估在经产妇和初产妇中，一种新的、低剂量铜（175mm）宫内节育器（IUD）的有效性、安全性和耐受性，该节育器带有灵活的镍钛诺框架，装在预装的输送器中。
美国 12 个地点的机构审查委员会批准了这项由商业资助的项目。患者符合铜基宫内节育器（IUD）的标准纳入和排除标准，通常与疾病控制和预防中心 2016 年的美国避孕使用医学资格标准一致。在有资格的患者的月经周期的任何一天进行宫内节育器放置，前提是她没有怀孕。主要结局指标是在这项为期 1 年的研究中评估疗效（通过 Pearl 指数衡量），并进行为期 2 年的扩展。次要结局指标包括放置成功率、放置的难易程度、通过不良事件衡量的安全性以及通过停药率和出血及点滴出血模式衡量的耐受性。
共有 286 名妇女提供了 5640 个可评估妊娠的周期。患者平均年龄为 27.1 岁。初产妇占患者的 60.8%。在 36 个月的观察期内，我们发现了两例妊娠（Pearl 指数 0.46[95%CI0.06-1.67]）和 10 例严重不良事件；没有一个与研究相关。283 名参与者（99.0%）成功放置。中位（范围）持续时间为 2.7 年（0-3.4 年）。我们发现 5 例（1.8%）脱落，0 例子宫穿孔，1 例盆腔炎报告。不良事件促使 30 名妇女（10.6%）在使用第一年早期停药，其中 23 名（8.1%）因出血、疼痛或两者兼有的问题停药。总共 107 名（37.8%）完成了 36 个月的设备使用。每个周期的平均出血天数从第 1 周期的 7.6 天减少到第 13 周期的 5.2 天。
在这项由美国食品和药物管理局进行的 2 期临床试验中，新型低剂量铜和镍钛诺 IUD 表现出了高疗效和安全性，值得进一步在 3 期临床试验中进行更广泛的研究。
ClinicalTrials.gov，NCT02446821。
Sebela 制药公司。
