Comparison of two levonorgestrel-releasing intrauterine systems for the treatment of heavy menstrual bleeding: a randomised, controlled, phase 3 trial

Abstract

Purpose

To evaluate the levonorgestrel-releasing intrauterine system Donasert^® (also known as Levosert^®) compared with the reference product Mirena^® for the alleviation of heavy menstrual bleeding (HMB).

Materials and methods

A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert^® or Mirena^® and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram.

Results

Overall, 312 were randomised (158 to Donasert^® and 154 to Mirena^®). The mean (standard deviation) absolute change in MBL from baseline to 6 months in the per-protocol population (N = 300) was −130 (71.8) mL and −127 (67.3) mL in the Donasert^® and Mirena^® groups, respectively; non-inferiority of Donasert^® was confirmed (p-value <0.0001). Successful treatment of HMB (MBL <80 mL) and a decrease to ≤50% of baseline MBL was achieved in 139/154 (90.3%) and 126/146 (86.3%) participants in the Donasert^® and Mirena^® groups, respectively and the between-treatment difference was non-significant. Most adverse events were mild in severity. Only two device expulsions occurred in the study and there were no uterine perforations.

Conclusions

Donasert^® has equivalent efficacy and safety during the first 6 months foralleviation of HMB compared to the reference device, Mirena^®.

Trial registration number

348 (Clinical Trials Registry of the Ministry of Health of the Russian Federation, http://grls.rosminzdrav.ru/default.aspx)

两种左炔诺孕酮宫内缓释系统治疗月经过多的比较:一项随机、对照、3期临床试验 摘要

目的:评价左炔诺孕酮宫内缓释系统Donasert$\text{R}$（也被称作Levosert$\text{R}$）与对照品曼月乐缓解月经过多（HMB）的效果。材料和方法:一项3期多中心、非劣效性、主动对照研究, 对象是主要症状为HMB（月经量[MBL]≥80毫升）的未绝经女性, 将其随机分为Donasert$\text{R}$或曼月乐组, 并随访6个月。使用一个经过验证和修订的Wyatt月经象形图版本评估MBL的。结果：总体而言, 312人被随机分组（Donasert$\text{R}$组158人, 曼月乐组154人）。Donasert$\text{R}$和曼月乐组受试者（共300人）MBL从基线到6个月的平均（标准差）绝对变化分别为-130 （71.8）毫升和-127 （67.3）毫升；证实Donasert$\text{R}$的非劣效性（p值< 0.0001）。两组受试者均成功治疗HMB （MBL <80毫升）。其中Donasert$\text{R}$组有139/154 （90.3%）, 曼月乐组有126/146 （86.3%）受试者分别达到基线MBL的0%, 治疗之间的差异不显著。大多数不良事件的严重程度较轻。研究中只发生了两次节育器排出事件, 没有子宫穿孔。结论:与对照品曼月乐相比, Donasert$\text{R}$在HMB的前6个月中具有同等的疗效和安全性。试验注册号:348（俄罗斯联邦卫生部临床试验登记处, http://grls.rosminzdrav.ru/default.aspx）

Keywords:

• Donasert^®
• heavy menstrual bleeding (HMB)
• abnormal uterine bleeding
• levonorgestrel intrauterine system (LNG-IUS)
• Levosert^®
• Mirena^®

Disclosure statement

No potential conflict of interest was reported by the author(s).