The use of different doses levonorgestrel-releasing intrauterine system (LNG-IUS): real-world data from a multicenter Italian study

Abstract

Purpose

Current research fails to adequately inform about the differential use of available levonorgestrel-releasing intrauterine systems (LNG-IUSs) in real life. Aim of our study was to compare the characteristics, satisfaction, continuation rates, and adverse effects between users of the high-dose LNG-IUS (52 mg) and of the low dose LNG-IUS (13.5 mg and 19.5 mg).

Materials and Methods

A prospective cohort study was performed in two Services for Family Planning in normal menstruating women with the inclusion of all new prescriptions of LNG-IUS for contraception. Women were followed for a mean of 9.1 ± 2.6 months after placement.

Results

109 women (mean age of 39.8 ± 8.7 years old) were included, 69.7% using a high dose LNG-IUS and 30.3% using a low dose LNG-IUS. Women with a low dose LNG-IUS were significantly younger, thinner, more nulliparous, with fewer vaginal deliveries and C-sections, with a lower menstrual flow length and with more previous use of short-acting reversible contraceptives (p < 0.05). LNG-IUS continuation was similar and very high at the last follow-up: 100 vs. 94.7% in the low and high dose LNG-IUS groups, respectively (p = 0.18). Satisfaction with treatment at the end of the study was similar between different LNG-IUS doses (p = 0.85), with 78.9% being satisfied/very satisfied. Bleeding patterns were significantly different between the two LNG-IUS doses (p < 0.0001). Diagnosis of dysfunctional cysts was more frequent in women with high dose compared to low dose LNG-IUS (22.2 vs. 12.1%), albeit not significantly.

Conclusions

We have shown a clear differential use of available LNG-IUS in clinical practice, both as baseline characteristics and as different outcomes, primarily for bleeding patterns. However, all these systems were associated with a very high rate of satisfaction and continuation.

应用不同剂量的左炔诺孕酮宫内缓释系统(LNG-IUS):来自意大利一项多中心研究的真实数据 摘要

目的:目前的研究未能充分说明在现实生活中应用左炔诺孕酮宫内缓释系统(LNG-IUSs)的不同用途。我们研究的目的是比较高剂量LNG-IUS (52 mg)和低剂量LNG-IUS (13.5 mg和19.5 mg)应用者之间的特征、满意度、延续率和不良反应。

材料和方法:在两个计划生育服务中心对月经正常的女性进行一项前瞻性队列研究, 包括所有首次应用LNG-IUS避孕的女性。随访时间为平均9.1±2.6个月。

结果:109名女性(平均年龄39.8±8.7岁)被纳入, 69.7%的妇女应用高剂量LNG-IUS, 30.3%的妇女应用低剂量LNG-IUS。应用低剂量LNG-IUS的女性明显更年轻、更苗条、阴道分娩和剖腹产次数更少、月经周期更短, 应用更多短期可逆避孕药(p＜0.05)。在最后一次随访时, LNG-IUS的持续应用情况相似, 且非常高：低剂量LNG-IUS组为100 %, 高剂量LNG-IUS组为94.7% (p = 0.18)。在研究结束时, 不同LNG-IUS剂量的患者对治疗的满意度相似(p=0.85), 78.9%的患者满意/非常满意。两种LNG-IUS剂量的出血模式有显著差异(p < 0.0001)。与低剂量LNG-IUS相比, 高剂量LNG-IUS中功能失调囊肿的诊断更为常见(22.2% vs. 12.1%), 尽管没有显著性差异。

结论:我们已经表明, 在临床实践中, LNG-IUS的应用无论是在基线特征, 还是在不同的结局都存在明显的差异, 但都主要用于治疗出血。并且, 所有剂量的宫内缓释系统都有很高的满意度和持续性。

Keywords:

• LARC
• levonorgestrel
• intrauterine systems
• bleeding
• satisfaction
• ovarian cyst
• side effects

Disclosure statement

G. Grandi received honoraria for sponsored lectures and participation in advisory boards from Bayer AG, Teva/Theramex, Sandoz Novartis, Exeltis Italy, Merck Sharp & Dohme and Effik Italy. The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.