Results of a 5-year contraceptive trial in parous and nulliparous women with a new LNG-IUS

Abstract

Objective: To report on the contraceptive performance and continuation of a new T-shaped LNG-IUS, releasing 20 μg of levonorgestrel/day, in both parous and nulliparous nulliparous women after 5 years of use.

Materials and methods: An observational prospective contraceptive study conducted in parous and nulliparous women up to 48 years of age.

Results: The study was conducted in a sample size of 356 women of whom 67.1% were parous and 32.9% were nulliparous with mean age of 35.1 (range 15–48). The total cumulative observation period was 27 269 woman-months. Only one accidental pregnancy was observed and two expulsions were reported with no partial expulsions. There were 12.7% medical removals for abnormal bleeding, pain and other medical reasons, mostly not related to the use of the LNG-IUS, and 13.3% removals in women wishing to become pregnant. The discontinuation rate at 5 years amounts to 25.7% including women with pregnancy wish, who used the LNG-IUS for an average of 44 months. There were no serious adverse events (e.g. perforation, pelvic inflammatory disease).

Conclusion: The LNG-IUS used in this study is highly effective and well tolerated resulting in a high continuation of use. The only two expulsions that occurred during the study is remarkable. The ease and safety of insertion together with optimal retention is considered an advance in intrauterine contraceptive device technology.

Chinese abstract

目的：报告一种每天释放20µg左炔诺孕酮的新型T型LNG-IUS节育器在经产妇女和未产妇女中使用5年的避孕性能和持续性。

材料与方法：对48岁以下的经产和未生育妇女进行观察性前瞻避孕研究。

结果：本研究共纳入356名妇女, 其中67.1%为经产妇女, 32.9%为未经产妇女, 平均年龄为35.1岁 (年龄范围15-48岁) 。总累积观察期为27269个女性月经周期。仅观察到一次意外怀孕, 报告两次脱落且非部分脱落。由于异常出血, 疼痛和其他医疗原因, 12.7%的受试者取出LNG-IUS, 且大部分与使用LNG-IUS无关。13.3%希望怀孕的妇女取出了LNG-IUS。包括希望怀孕的妇女在内, 新型LNG-IUS 5年的中止率为25.7%, 受试者使用的平均时间为44个月。未发生严重的不良事件 (如穿孔, 盆腔炎性疾病) 。

结论：本研究中使用的LNG-IUS是高度有效的, 在长期使用中耐受性良好。值得注意的是在研究中发生了两次脱落。轻松安全的置入和理想的保持性使得新型LNG-IUS被认为是宫内节育装置技术的进步。

Keywords:

• Contraception efficacy
• Femilis LNG-IUS
• levonorgestrel
• safety 5-year continuation

Acknowledgements

The authors are grateful to Prof. Dr. G. Van Maele, Department of Medical Informatics and Statistics, University Hospital Ghent, Belgium, for statistical analysis of the data.

Declaration of interest

Dirk Wildemeersch, MD, PhD, has been involved in the optimization of new, innovative, drug delivery systems for use in the uterus. He did not receive any financial compensation of any kind. He is currently advisor in devising new concepts in controlled release for contraception, gynecological treatment, and prevention of infectious diseases. Norman Goldstuck and Geert Jackers: nil.