A multicentre, open-label, randomised phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral contraception in young women of reproductive age

Abstract

Objectives: To compare user satisfaction and adverse events (AEs) with a levonorgestrel intrauterine system (LNG-IUS 8; average levonorgestrel release rate approximately 8 μg/24 h over the first year [total content 13.5 mg]) and a 30 μg ethinyl estradiol/3 mg drospirenone (EE/DRSP) combined oral contraceptive (COC) in a population of young women.

Methods: Nulliparous and parous women (aged 18–29 years) with regular menstrual cycles (21–35 days) were randomised to LNG-IUS 8 or EE/DRSP for 18 months. The primary endpoint was the overall user satisfaction rate at month 18/end of study visit.

Results: Overall, 279 women were randomised to LNG-IUS 8 with attempted placement and 281 women were randomised to EE/DRSP and took ≥1 pill; the mean age was 23.7 and 23.9 years, and 77.4% and 73.3% were nulliparous, respectively. At month 18/end of study, 82.1% and 81.9% of women, respectively, reported being ‘very satisfied’ or ‘satisfied’ with their treatment; however, significantly more LNG-IUS 8 users reported a preference to continue their treatment post-study (66.2% vs 48.8%; p = 0.0001). There were two pregnancies (one ectopic pregnancy, one spontaneous abortion) reported in the LNG-IUS 8 group and six (three live births, two spontaneous abortions, one induced abortion) in the EE/DRSP group.

Conclusions: LNG-IUS 8 and EE/DRSP were associated with similarly high user satisfaction rates. However, LNG-IUS 8 users were significantly more likely to prefer to continue their contraceptive method post-study, indicating that a levonorgestrel intrauterine system is an appealing contraceptive option for young women.

Chinese abstract

目的: 以年轻女性为研究人群, 比较左炔诺孕酮宫内系统（LNG-IUS 8; 第一年左炔诺孕酮平均释放率约为8 μg/24h[总含量13.5mg]）和含30μg 炔雌醇/3mg屈螺酮（EE/DRSP）复方口服避孕药（COC）的患者满意度和不良事件（AEs）

方法: 月经周期规律（21-35天）的未生育妇女和已生育妇女（年龄18-29岁）随机分配入LNG-IUS 8或EE/DRSP组, 使用18个月。主要终点是在使用18个月/研究随访结束时所有的患者满意率。

结果: 279名妇女随机分配入LNG-IUS 8, 且放置位置合适, 281名妇女随机分配入EE/DRSP组, 每天服用1片; 两组平均年龄分别为23.7岁和23.9岁, 未生育妇女分别占77.4%和73.3%。在18个月/研究结束时, 分别有82.1%和81.9%的妇女对其治疗表示”非常满意”或”满意”; 但是, 治疗结束后, 更多的LNG-IUS 8使用者有意愿在研究结束后继续治疗, 差异有统计学意义（66.2% vs 48.8%; p=0.0001）。LNG-IUS 8组有两例怀孕（异位妊娠1例, 自然流产1例）, EE/DRSP组有6例怀孕（活产3例, 自然流产2例, 人工流产1例）。

结论: LNG-IUS 8和EE/DRSP均有相似且较高的患者满意率。但是, LNG-IUS 8使用者在治疗后更有可能愿意持续原有的避孕方法, 这表明左炔诺孕酮宫内系统对于年轻女性是一种比较吸引人的避孕选择。

Keywords:

• Combined oral contraception
• intrauterine contraception
• intrauterine system
• LARC
• LNG-IUS
• long-acting reversible contraception

Acknowledgements

We would like to thank the participating investigators and coordinators at the 42 study centres, Liisa Lindström for management of the study and Gerald Staedtler for assistance with statistical analyses.

Disclosure statement

Lynn Borgatta has been a speaker at scientific meetings for Bayer HealthCare and her department has received research funding from Bayer HealthCare. Kai J. Buhling is on the speakersã bureau of Bayer HealthCare and his department has received research funding from Bayer HealthCare. He has also taken part in advisory boards and has been an invited speaker at scientific meetings for Bayer AG, Dr. Kade Pharma GmbH, Dr. Kade/Besins Pharma GmbH, Jenapharm GmbH & Co KG, MSD/Merck, adpharm GmbH, and Gedeon Richter Pharma GmbH. Katrin Roth, Sarah Rybowski and Kimberly Rosen are employees of Bayer HealthCare. In development of the manuscript, medical writing support was provided by Laura Miller and Helen Attisha of Chameleon Communications, with the financial support of Bayer HealthCare.

Funding

This study was funded by Bayer HealthCare.